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14.0 - 16.0 years
12 - 16 Lacs
Gurugram
Work from Office
Job Title - Solution & Advisory Senior Manager (CL6) - Life Sciences Management Level: 6-Senior Manager Location: Bengaluru, BDC10A Must-have skills: Life Sciences Good to have skills: Knowledge of emerging technologies, cloud computing, and cybersecurity best practices. Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Develop and execute technology transformation strategies, oversee implementation projects, and optimize digital capabilities for business efficiency. We are: Accentures Strategy & Consulting Global Network is a network of over 9,000 strategy and management consulting specialists connecting across industries and functions to support clients and partners from business development through sales to delivery. Specialty areas entail Strategy, CFO & Enterprise Value, Technology Strategy & Advisory, Talent & Organization, Supply Chain & Operations, Industry X, AI, and Song. Solution and Innovation (S&I) Advisory. The S&I Advisory team is a specialty sales advisory service within Accentures Strategy & Consulting Global Network. We are specialists aligned to Accentures priority business offerings with expertise in how to go-to-market and best position Accenture to win consulting work. We are a sales lab that works closely with sales leadership, equipping them with relevant market insights, customized sales messages, and curated sales assets to originate, sell, and win. You are: An experienced Senior Consulting Leader with a deep understanding of Life Sciences industry. You will build and lead a team focused on providing pre-sales solution support, shaping deals, and developing strategic proposals for clients in Life Sciences . You have expertise in pharmaceutical and medical device R&D processes, compliance, and digitalization strategies . You are also proficient in guiding S/4HANA implementations and integrations tailored to Life Sciences clients. The Work: As a Solution & Innovation Advisory Senior Manager, you provide high touch sales support to our Global Life Sciences team, including: Planning and Origination Support annual planning to outline sales targets, target clients, and enhancement of sales assets. Conduct ongoing research to identify which companies to target over next 6-12 months. Support sales / pipeline reviews with leaders. Prepare for and support first conversations with potential clients. Proposals / Orals Define proposal response requirements and best sales messaging approach. Bring the latest knowledge and best of content to each opportunity (e.g., industry trends benchmarking, competitive insights, etc.). Help shape the overall solution (approach, team, pricing, differentiators, etc.) to best fit the deal requirements. Prepare and help lead orals with innovating ways of selling to help differentiate Accenture. Content Management / Continuous Improvement Support development of go-to-market approach / assets. Maintain global repository of sales assets (e.g., proposals, stage 0 decks credentials, etc.). Conduct reviews (loss / delivery) with client teams to understand how we can improve sales and harvest deliverables Key Responsibilities: Team Building & Leadership :Build and lead a team providing deal solutioning services for Life Sciences clients. Expand the team to provide broader coverage across geographies over time. Industry-Specific Deal Support :Own the end-to-end deal process, from solution architecture to feasibility assessments and business case development for Life Sciences clients. Develop custom solutions for pharmaceutical R&D digitalization , including clinical trial management , data governance , and regulatory compliance , supported by S/4HANA . Tailored Multi-Team Engagement :Partner & Collaborate with multiple teams across Accenture involved in selling & delivering work including Market Leads, Client Account Leads, Global Network Teams, and other Sales Support teams (including other teams in S&I Advisory team). Thought Leadership & Asset Creation :Act as an industry expert, staying ahead of emerging trends such as AI in drug discovery , digital twins for clinical trials , and data-driven R&D insights , offering innovative insights on deals, and building strategic assets which could enhance Accentures competitive advantage in the market. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 14-16Years Educational Qualification: Masters Degree
Posted 1 month ago
0.0 years
0 - 2 Lacs
Kota, Jaipur
Work from Office
India's Hiring for Big Healthcare Enterprise KTPL Technologies Private Limited. Position Hiring: Engineer Trainee for Rajasthan No. of Vacancies: 20 (Looking for Freshers Only) Company Profile: About KTPL Technologies Pvt. Ltd.: Founded in 1993 by the late Mr. Vikram Kirloskar with the name of Kirloskar Theratronics Pvt. Ltd. and further changed to KTPL Technologies (formerly Kirloskar Technologies Pvt. Ltd.) w.e.f . began its journey with a vision to transform Indias healthcare landscape through advanced medical technologies and solutions. What started as a modest venture with a team of 15 employees across three locations has evolved into a robust organization of 650+ professionals, delivering excellence across India and globally. Over the past 30 years, KTPL has built a reputation for reliability, customer focus, and pioneering spirit. The company has served more than 75,000 customers , spanning leading public and private healthcare institutions, and has successfully executed international healthcare technology projects. In 2024, KTPL entered an exciting new phase under the leadership of renowned businessman Mr. Kamal Gupta , who took over the company with a vision to scale new heights, strengthen the foundation, and accelerate KTPLs journey toward global excellence. Position Objective: Responsibilities include planning and managing the services of medical equipment and optimal use of resources. Job Responsibilities: Service Support: Responsible for providing periodic maintenance services, timely resolution for equipment malfunctions, troubleshooting, and repair of electronic and electromechanical equipment onsite service. Preventive and Corrective maintenance of Biomedical Equipment. Coordinate with service contractors for maintenance, calibration, and collection of service documents. Training customers on equipment operation, maintenance procedures and process related to the upkeep of equipment. Key Account/Customer Relationship Management: Responsible for building and managing key customers as well as building and strengthening customer relations by timely follow up and support to the customers. Responsible for the closure of all assigned calls. Timely submission of documents (service reports, PM reports, etc.) to the branch office. Responsible for the daily scheduling of engineers and providing daily updates to BSM. Follow up with the service coordinator for spares required to rectify the equipment. Responsible for grooming of Engineers technicians reporting to him. Education and Experience Requirements: B.E/B.Tech in Biomedical Engineering/ Medical Electronics/ Electronics & Electrical / Electronics & Telecommunication, and Instrumentation. Diploma in Electronics Engineering, Electronics & Telecommunications, or Electrical Engineering. Experience: Fresher Expertise in the repair, calibration, and maintenance of medical equipment. High level of customer focus and good communication skills with a pleasing personality. Self-motivated and self-directed with the ability to create and manage their own schedule. WE REQUIRE AMBITIOUS PEOPLE WITH PROFESSIONAL IMAGE, GOOD ATTITUDE, AND MENTALITY TO GROW WITH THE COMPANY. Salary Range: Salary will not be a constraint for the right candidate, and it may vary based on experience and skill set.
Posted 1 month ago
3.0 - 8.0 years
5 - 11 Lacs
Bengaluru
Work from Office
Job description: Roles and Responsibilities Role Overview Job Title: Territory Sales Manager Functional Area: Domestic Sales Reports To: Area Sales Manager Key Accountabilities Meet Customers regularly as per Sales Plan to ensure complete coverage of the territory. Develop and maintain a high level of product knowledge and relevant medical information for self to be able to provide the same to customers. Demonstration of product whenever required to educate the customers. Develop & maintain a thorough understanding of Client base, ensure a close working relationship exists between the organization, Key Accounts and KOLs. Sampling and feedback. Own and meet/exceed annual sales targets. Attend and represent the organization in meetings, seminars, conferences etc. Effectively implementing marketing campaign with effective customer conversion Work in close co-ordination with distributors as per company policies to increase the sales. Map Competition actively and share periodic/monthly report with the Manager to assist in alignment of strategy. New product launches, shift in usage pattern, customer feedback on competitions product to be monitored and reported. Identify and strategize penetration plans for new markets and customers. Drive timely collections and ensure DSO days are maintained as per the annual plan. Responsible for high cost-effectiveness in business expenses Manage customer escalations in timely manner and according to SMTs policy and requirement. Ensure 100% compliance with SOPs and code of conduct of the organization is followed at every level and transactions. Key Measures Achievement of Targets Stock Management and availability assurance Payment receivables and credit management. Discipline and compliance to Policies, SOPs and Regulations Eligibility criteria 5 + years of total experience. At least 2-3 years of experience in Cardiovascular Medical Devices / Pharma Preferably from Interventional Cardiology or Cardiovascular background
Posted 1 month ago
3.0 - 8.0 years
3 - 5 Lacs
Noida
Work from Office
Hiring Production Assistant Executive with experience in plastic & rubber manufacturing, moulding, assembly line, vendor coordination. Must be skilled in documentation & MS Excel, with strong organizational abilities. Contact on whatsaap@8800096384 Required Candidate profile Looking for a candidate with knowledge of plastic/rubber moulding (injection/compression), assembly line ops, production docs, Excel (VLOOKUP, Pivot), vendor mgmt & strong team communication skills.
Posted 1 month ago
2.0 - 7.0 years
2 - 6 Lacs
Jaipur
Work from Office
Experience required Should have exp of Hospital Sales Should have exp of Critical Care Division or Surgical Sales if interested pl. contact on 9643975459
Posted 1 month ago
7.0 - 10.0 years
12 - 22 Lacs
Chennai
Work from Office
Role & responsibilities Identify and pursue new business opportunities in EMS, especially in sectors like medical devices, industrial automation, and defense and aerospace. Develop and maintain strong relationships with clients, understanding their manufacturing needs and aligning them with company capabilities. Collaborate with cross-functional teams (engineering, manufacturing, supply chain) to deliver tailored solutions. Lead the sales pipeline from prospecting to closing, including contract negotiations and pricing strategies. Monitor market trends, competitor activity, and customer feedback to refine business strategies. Conduct market research to understand trends, customer needs, and competitive landscape. Develop and implement sales strategies to achieve revenue targets. Negotiate contracts, pricing, and terms with clients and suppliers. Represent the company at industry events, trade shows, and networking opportunities. Monitor analyze sales performance, providing regular reports to senior management. For More details about JD & RR can be viewed in Rikun website/Career page. Preferred candidate profile Strong understanding of B2B sales cycles, lead generation, and sales account mgmt. Excellent communication, negotiation, and interpersonal skills. Analytical mindset with strong problem-solving capabilities. Proficiency in CRM tools (e.g., Salesforce, HubSpot) and Microsoft Office Suite. Knowledge of manufacturing processes and supply chain basics is an advantage. Self-starter with high energy and drive to succeed. Comfortable with domestic and international travel for client visits and trade shows. Ability to work independently and as part of a cross-functional team.
Posted 1 month ago
5.0 - 10.0 years
9 - 10 Lacs
Bharuch, Olpad, Surat
Work from Office
Role & responsibilities Giving lectures in classes and organizing conferences regarding program studies and related topics. Developing proper coursework of subjects for the students Answering queries and questions of the students to improve their understanding and knowledge of the subject. Evaluating assessments and projects of the students. Publishing papers and reports. Assisting the college administration in making important decisions. Guiding students to broaden their overall skills and knowledge Preferred candidate profile Carries a Ph.D. in Nursing Field Possess teaching Experience in a university setting. A portfolio for Published works, which is advantageous Experience in attending conferences and academic events. Experience in research, writing, and interpersonal communication. A passion for teaching and connecting with students. Patience, understanding, and a willingness to support others.
Posted 1 month ago
3.0 - 5.0 years
5 - 9 Lacs
Chennai
Work from Office
The Clinical Application Specialist is responsible for providing clinical education and support for Aerogen nebulizer products in hospital accounts within the designated India region. The successful candidate will collaborate with team members, the Commercial Director, and other stakeholders to optimize customer experience, maximize sales, and gain market share. What are the key responsibilities Increase Aerogen nebulizer utilization in Acute Care (Hospital System) to gain market share and support sales targets. Provide clinical user support. Deliver customer training in the hospital setting, empowering customers to use Aerogen nebulizers effectively and independently. Comply with mandatory training and attend local and abroad training programs to maintain knowledge. Collaborate with the Country Manager, Aerogen teams, and distributors to develop innovative activities and achieve sales targets. Maintain relationships with key opinion leaders (KOLs) and important stakeholders. Understand customer needs and objectives to develop tailored solutions that maximize market potential. Stay informed about competitors' products, activities, and strategies in the Indian market. What education and experience are required Degree and/or recognized Clinical Education. Minimum 3-5 years of relevant experience in the medical field. Experience in respiratory therapy, including training and responsibility is preferred What key skills will make you great at the role Fluent in English, both verbal and written communication. Excellent interpersonal skills and the ability to build strong relationships. In-depth product and procedure knowledge to effectively communicate with key stakeholders. Self-disciplined, organized, and takes ownership of business objectives. Highly motivated and driven to succeed. Team player and independent thinker. Ability to positively influence thinking, behavior, and gain commitment. Resident within India with flexibility to travel within India up to 70%. What is it like to work at Aerogen Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. Theres something for everyone! Here is an idea of what we offer: Competitive commission plan. Above market life insurance. Opportunities for development and professional growth. "Aerogen Connect" our employee-led program that helps our global teams unite and have fun. We donate 1% of profits and time to charities and organizations.
Posted 1 month ago
2.0 - 7.0 years
4 - 9 Lacs
Mumbai
Work from Office
LOCATION Mumbai West FUNCTION AND/OR JOB ID SALES BUSINESS ABBOTT PRIMARY CARE CORE JOB RESPONSIBILITIES 1. To analyse and prepare working plan for the territory basis the data provides/ market research 2. To be able to follow up, monitor and achieve targets of the territory 3. Implementation & execution of all strategies 4. Stakeholder engagement- doctors, stockist, retailers, chemists and institutions pharmacy 5. Discipline and punctual with set timelines for multiple internal processes 6. Basic computer skills- excel working, word & email exchanges 7. Fast learner and adaptable to change in market 8. Strong communication skills (verbal)- English and local language 9. Effective in-clinic performance 10. Basic understanding and ability to explain anatomy physiology and product portfolio 11. Organizing Camps (CME) as per the division strategy and customer needs 12. Prescription audit for Abbott brands and other competitors brands 13. Generate POBs for Abbott brands as per the business plan REQUIRED EXPERIENCE Experience 2+ years of experience Fresher with good communication skills and analytical skills may also consider PREFERRED EXPERIENCE Candidate with prior / current experience in same therapy. Candidate from MNC and Top Indian pharma companies will have added advantage LOCATION: India > Mumbai : Unit 3 Corporate Park t
Posted 1 month ago
2.0 - 6.0 years
3 - 6 Lacs
Kolkata
Work from Office
Engage in the sales and promotion of medical devices, specifically targeting corporate hospitals of the city. Conduct meetings with a diverse range of healthcare professionals to discuss the benefits and applications of the medical devices.
Posted 1 month ago
3.0 - 4.0 years
5 - 10 Lacs
Noida
Work from Office
Requisition #: 16946 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys software has enabled innovators across industries to push boundaries by using the predictive power of simulation. From sustainable transportation to advanced semiconductors, from satellite systems to life-saving medical devices, the next great leaps in human advancement will be powered by Ansys. Innovate With Ansys, Power Your Career. SUMMARY The engineer will join the PowerArtist Elaboration and PDB team. He/she will develop features and algorithms for the power analysis tool (PowerArtist) in area of Elaboration and/or Power-Database (PDB) using C++ language on Linux platform. He/she will be expected to write test cases for the features developed and assigned to him/her to increase the robustness of the tool. RESPONSIBILITIES Learn the team s software development processes. Diagnose and fix code problems. Deliver code and scripts that meet requirements on schedule. Ensure that code is efficient, scalable, maintainable, extensible, robust and easy to understand. Create unit, regression and/or system-level tests to thoroughly validate new features or changes. Communicate clearly and work closely with the team to refine solutions and to describe changes that may affect others. Learn and follow best practices in software engineering. MINIMUM QUALIFICATIONS B.E./BTech. or M.E./MTech. degree in Electronics Engineering, Computer Science, or related field like VLSI Working knowledge in C or C++ Working knowledge of the Linux operating system Strong basic knowledge of data structures, algorithms. Debugging skill is a plus. Ability to learn quickly, understand complex systems and to work closely with others Ability to complete high-quality work on time PREFERRED QUALIFICATIONS Some exposure to EDA domain technologies. At Ansys, we know that changing the world takes vision, skill, and each other. We fuel new ideas, build relationships, and help each other realize our greatest potential. We are ONE Ansys. We operate on three key components: our commitments to stakeholders, our values that guide how we work together, and our actions to deliver results. As ONE Ansys, we are powering innovation that drives human advancement Our Commitments: Amaze with innovative products and solutions Make our customers incredibly successful Act with integrity Ensure employees thrive and shareholders prosper Our Values: Adaptability: Be open, welcome what s next Courage: Be courageous, move forward passionately Generosity: Be generous, share, listen, serve Authenticity: Be you, make us stronger Our Actions: We commit to audacious goals We work seamlessly as a team We demonstrate mastery We deliver outstanding results VALUES IN ACTION Ansys is committed to powering the people who power human advancement. We believe in creating and nurturing a workplace that supports and welcomes people of all backgrounds; encouraging them to bring their talents and experience to a workplace where they are valued and can thrive. Our culture is grounded in our four core values of adaptability, courage, generosity, and authenticity. Through our behaviors and actions, these values foster higher team performance and greater innovation for our customers. We re proud to offer programs, available to all employees, to further impact innovation and business outcomes, such as employee networks and learning communities that inform solutions for our globally minded customer base. WELCOME WHAT S NEXT IN YOUR CAREER AT ANSYS At Ansys, you will find yourself among the sharpest minds and most visionary leaders across the globe. Collectively, we strive to change the world with innovative technology and transformational solutions. With a prestigious reputation in working with well-known, world-class companies, standards at Ansys are high met by those willing to rise to the occasion and meet those challenges head on. Our team is passionate about pushing the limits of world-class simulation technology, empowering our customers to turn their design concepts into successful, innovative products faster and at a lower cost. Ready to feel inspired? Check out some of our recent customer stories, here and here . At Ansys, it s about the learning, the discovery, and the collaboration. It s about the what s next as much as the mission accomplished. And it s about the melding of disciplined intellect with strategic direction and results that have, can, and do impact real people in real ways. All this is forged within a working environment built on respect, autonomy, and ethics. CREATING A PLACE WE RE PROUD TO BE Ansys is an S&P 500 company and a member of the NASDAQ-100. We are proud to have been recognized for the following more recent awards, although our list goes on: Newsweek s Most Loved Workplace globally and in the U.S., Gold Stevie Award Winner, America s Most Responsible Companies, Fast Company World Changing Ideas, Great Place to Work Certified (China, Greece, France, India, Japan, Korea, Spain, Sweden, Taiwan, and U.K.). For more information, please visit us at www.ansys.com Ansys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other protected characteristics. Ansys does not accept unsolicited referrals for vacancies, and any unsolicited referral will become the property of Ansys. Upon hire, no fee will be owed to the agency, person, or entity.
Posted 1 month ago
7.0 - 12.0 years
25 - 30 Lacs
Gurugram
Work from Office
Work Flexibility: Onsite What will you do: The Distributor Manager, Emerging Asia, is responsible for leading Inari s commercial success across India, Malaysia, Thailand, and future Southeast Asia markets. This role owns all aspects of distributor performance from partner selection and onboarding to training, commercial execution, and market development. As the key interface between Inari and its distributor network, the manager will drive product introduction, therapy adoption, and consistent procedural excellence. Success in this role requires strong commercial leadership, hands-on field presence, and close collaboration with internal teams including medical, marketing, supply chain, and regulatory. This position reports to the APAC General Manager and involves up to 70% travel across the region. Lead full distributor lifecycle management across assigned markets from partner selection and onboarding to training, performance management, and transitions when needed. Accelerate commercial growth in nascent markets by working hands-on with distributor teams to build early momentum, drive therapy adoption, and establish foundational commercial and clinical execution. Deliver clinical and procedural excellence by supporting pre- and post-case discussions, attending key procedures, and ensuring best-practice protocols are followed to optimize patient outcomes. Develop high-impact training and education programs for distributor reps and hospital staff in collaboration with medical and marketing teams, including workshops, live case support, and peer-to-peer initiatives. Establish and grow key accounts through structured engagement, physician education, and clear therapy development plans that convert early adopters into consistent users. Track and drive performance metrics including sales results, case volumes, product mix, and activity execution using CRM tools and regular business reviews. Maintain pricing discipline and commercial integrity by ensuring alignment with agreed terms and monitoring pricing practices across markets and accounts. Ensure full compliance with company policies, distributor agreements, and local regulatory and ethical standards while actively contributing to a culture of accountability and integrity. Proven ability to lead distributor execution, drive commercial growth, and develop early markets with minimal structure. Strong clinical acumen and comfort supporting procedures, educating physicians, and shaping therapy adoption. Excellent communicator and coach able to build trust, influence stakeholders, and elevate distributor capabilities. What you need: High personal integrity with a disciplined, compliant approach to operating in complex, cross-cultural environments Bachelor s degree required; life sciences, business, or engineering preferred. Minimum 7 years of relevant experience in medical devices or healthcare, with at least 3 years managing distributor markets. Demonstrated success in market development and clinical engagement in emerging Asia. Experience supporting case-based selling and physician education across multiple specialties. Experience launching new therapies in nascent or underpenetrated markets. Prior success building distributor teams or transitioning to direct models. Advanced degree (MBA, MPH, or related) is a plus. Familiarity with case support models and therapy development in thrombectomy or interventional specialties. Extensive travel required within Asia Travel Percentage: 80%
Posted 1 month ago
3.0 - 4.0 years
0 - 1 Lacs
Kochi, Hyderabad, Bengaluru
Work from Office
About the Role: We are looking for a Dynamic and result-oriented Sales & Business Development Executive with experience in medical device sales and a strong understanding of hospital requirements. The ideal candidate should have excellent communication skills, the ability to generate new business opportunities, and a passion for growing sales in the healthcare sector. Key Responsibilities: Sales & Lead Generation - Identify potential clients, generate leads, and convert them into business opportunities. Client Relationship Management - Build and maintain strong relationships with hospitals, clinics, and distributors. Product Demonstrations - Explain and showcase medical equipment to potential clients, including doctors and procurement teams. Market Research & Business Strategy - Analyze market trends, competitor activities, and suggest strategies to increase sales. Revenue Growth Meet and exceed sales targets while ensuring customer satisfaction. Contract & Negotiation Close deals, manage pricing discussions, and handle client agreements. Qualifications & Skills: Bachelors/Masters degree in Business, Marketing, Biomedical, or related field 2+ years of experience in medical device sales/business development Strong knowledge of hospital procurement processes and medical equipment Excellent communication, negotiation, and presentation skills Ability to travel for client meetings and product demonstrations
Posted 1 month ago
1.0 - 6.0 years
3 - 6 Lacs
Mumbai, Pune, Ahmedabad
Hybrid
Responsibilities: Should have Experience in Medical Device industry. Maintaining solid working relationships with customers by ensuring that their needs are met and resolving complaints in a timely manner. Responsible for revenue generation as per the monthly / quarterly / annual budget. Analyzing sales and marketing data to determine the most effective sales and marketing techniques. Lead the Medical Representatives / Sales Executives in the region Developing innovative sales strategies to increase sales within an assigned territory. Plan advertising services for the territory that is in keeping with the brand of the company and can increase name recognition. Timely reporting of weekly reports and trackers for focus products. Recommending and organizing marketing activities. Attend trade associate meetings as a representative of the company in order to promote products and increase sales numbers for the territory.
Posted 1 month ago
3.0 - 8.0 years
9 - 14 Lacs
Bengaluru
Work from Office
Job Description Summary Job Summary: The Product Safety and Standards Compliance Engineer will be responsible for ensuring that all medical devices and related products adhere to applicable safety standards and regulations. The role involves conducting thorough safety assessments, identifying potential hazards, collaborating with design teams to mitigate risks, and maintaining compliance throughout the product lifecycle. This position is crucial for prioritizing patient safety and ensuring regulatory adherence within the healthcare industry. . Job Description Key Responsibilities: Risk Assessment and Hazard Identification: Perform detailed safety analyses on new and existing medical devices to identify potential hazards and assess their associated risks using methodologies like Failure Mode and Effect Analysis (FMEA) and other risk management tools. Conduct thorough reviews of product designs, materials, and manufacturing processes to identify potential safety concerns. Compliance with Regulatory Standards: Stay updated on relevant international and national healthcare regulations (e.g., FDA, ISO 13485, IEC 60601) and ensure products comply with all applicable standards. Develop and maintain compliance documentation, including technical files, risk management plans, and product safety reports. Design Input and Collaboration: Work closely with product development teams to integrate safety considerations into product designs from the early stages of development. Provide technical expertise on safety standards and regulations to engineering teams to ensure safe product design and implementation. Testing and Certification: Oversee product testing and certification processes to verify compliance with safety standards, including collaborating with external testing laboratories. Analyze test results and interpret data to identify potential safety concerns. Incident Investigation and Corrective Action: Investigate reported product safety incidents, analyze root causes, and implement appropriate corrective actions to prevent recurrence. Monitor post-market surveillance data to identify safety trends and take proactive measures to address potential issues. Training and Awareness: Conduct training programs for cross-functional teams on product safety principles, regulatory requirements, and risk management practices. Required Skills and Qualifications: Bachelors degree in Biomedical Engineering, Mechanical Engineering, or a related field. Strong understanding of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601). Expertise in risk management methodologies and tools. Excellent analytical and problem-solving skills. Strong communication and collaboration skills to work effectively with cross-functional teams. Experience with product development lifecycle and design control processes. Ability to stay updated with emerging safety standards and regulatory changes. Preferred Qualifications: Master s degree in a related field. Certification in quality management systems or risk management. Prior experience in a similar role within the healthcare or medical device industry. Working Conditions: Office environment with occasional travel to manufacturing sites, testing laboratories, and industry conferences. Ability to work in a fast-paced and dynamic environment with strict regulatory timelines. Inclusion and Diversity . Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-Hybrid #LI-MP2 #EveryRoleIsVital Relocation Assistance Provided: Yes
Posted 1 month ago
2.0 - 5.0 years
5 - 9 Lacs
Bengaluru
Work from Office
Summary of the Position:The Product Support Engineering team is responsible for sustaining activities that support products in the field. This team is an integral part of the R&D Surgical Instrumentation organization and acts as a liaison between several cross-functional teams, including Design Control, MTO, Service, Regulatory Affairs, Clinical, Quality, and Commercial.JOB FUNCTIONSEssential FunctionsDuties are listed in order of greatest importance. Other responsibilities may be assigned. Technical Guidance: Provide technical advice and recommendations to influence internal and external stakeholders. Change Management: Review change plans and notices, ensuring proper implementation of product changes. Product Lifecycle Support: Apply engineering principles to the research and development of medical devices/technology and provide expertise to support development. Product Compliance: Ensure continuity of products and processes by assessing feasibility, research, design, and development. Maintain compliance with customer and non-customer requirements throughout the lifecycle, including transfer to production. Analytical Problem Solving: Utilize intermediate-level analytical techniques and previous experience to adapt or improve existing approaches. Engineering Direction: Provide general engineering direction, developing solutions by coordinating multiple resources to solve complex problems. Regulatory Compliance: Ensure adherence to regulatory, statutory, and legislative requirements for all project work. Autonomy & Decision Making: While generally following a specified course of action, the role allows autonomy to propose alternatives when necessary. Cross-Functional Awareness: Demonstrate an understanding of the broader business context, including external environmental factors that impact the role.QUALIFICATIONSMinimum RequirementBachelor s degree in Electrical, Mechanical Engineering, or related fieldMinimum of 5 years of experience in Medical Devices product development and design control processes.Preferred Experience: +2 years Proficiency with Polarion or similar requirements management software tools and PLM tools e.g. Windchill or Teamcenter.Strong understanding of systems engineering and modeling principles and practicesExperience in ophthalmology-related surgical medical devices (preferred)Strong problem-solving and analytical skillsAbility to collaborate across cross-functional teams and manage complex tasksFamiliarity with medical device development processes and regulatory requirements is preferredKnowledge, Skills and AbilitiesStrong Business awarenessSuccessful experience working cross-functionally, in matrix organizations and in global teamsStrong Collaborative Team player Problem SolvingStrategic AgilityEmployment scams: Alcon is aware of employment scams which make false use of our company name or leader s names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website, where you can search for open positions and apply directly.If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information, and check our website for current job openings. ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker
Posted 1 month ago
5.0 - 10.0 years
9 - 13 Lacs
Chennai
Work from Office
Sales Manager CGT (Single Use Solutions), India Job Location: Chennai, India Industry: Biopharma / Life Sciences / Medical Devices Roles and Responsibilities: Develop and execute strategic sales plans to achieve revenue targets for Single Use CGT Therapy. Identify key clients and prospects, including hospitals, clinics, and pharmaceutical companies. Lead and manage the sales team, providing guidance to achieve individual and team targets. Build and maintain relationships with key stakeholders, partners, and customers. Conduct market research to track trends and competitor activities. Negotiate contracts, pricing, and terms with customers. Monitor and report sales performance, adjusting strategies as needed. Work closely with the marketing team to develop targeted promotional campaigns. Oversee post-sales support to ensure customer satisfaction and retention. Qualifications & Requirements: Bachelor s/Master s degree in Biotechnology, Life Sciences, Bioprocessing, or Business Administration. 5+ years of experience in sales and business development in the Biopharma / Life Sciences sector. Strong understanding of Single Use CGT Therapy and related technologies. Excellent negotiation, communication, and leadership skills. Willingness to travel across regions
Posted 1 month ago
5.0 - 10.0 years
6 - 7 Lacs
Chennai
Work from Office
Develop and execute the product strategy for Drug Delivery Single Use Bags and Devices. Work closely with R&D, regulatory, and sales teams to ensure successful product development. Conduct market analysis to identify opportunities for new products and improvements. Define product specifications, pricing, and positioning. Manage product lifecycle, from conception to commercialization. Oversee regulatory compliance and quality standards. Develop sales training materials and marketing strategies. Build relationships with key industry experts and healthcare professionals. Qualifications & Requirements: Bachelor s/Master s degree in Biomedical Engineering, Biotechnology, or Life Sciences. 5+ years of experience in product management within the medical device industry. Expertise in Drug Delivery Single Use Bags and Devices. Strong knowledge of ISO 13485, FDA, and MDR regulations. Excellent project management and leadership skills.
Posted 1 month ago
2.0 - 7.0 years
2 - 3 Lacs
Chennai
Work from Office
We are seeking a Design Engineer with a Mechanical Engineering background to work on product design and development. The ideal candidate should have expertise in SolidWorks and experience in designing components for the medical device, biotech, or life sciences industry. Designation: Design Engineer Department: Product Design & Development Experience: Minimum 2 years in design engineering Industry/Background: Mechanical / Medical Device / Pharma / Lifesciences Industry Software Expertise: SolidWorks (mandatory), AutoCAD (preferred) Qualification: B.E / B.Tech Mechanical Engineering or related field Employment Status: Permanent Workplace Type: On-site Minimum Requirements: Minimum 2 years of experience in product design and development. Strong proficiency in SolidWorks for 3D modeling, drafting, and assembly design. Experience in designing plastic and metal components, sheet metal, and machined parts. Knowledge of GD&T, tolerance analysis, and material selection. Understanding of manufacturing processes, prototyping, and DFM/DFA principles. Ability to read and interpret engineering drawings. Exposure to ISO 13485 and medical device design standards is a plus. Strong problem-solving and analytical skills. Good communication and teamwork skills. Roles and Responsibilities: Design and develop medical devices and accessories as per industry standards. Create and modify 3D models, technical drawings, and assemblies using SolidWorks. Conduct DFM (Design for Manufacturing) and DFA (Design for Assembly) analysis. Work closely with R&D, production, and quality teams to ensure product feasibility. Prepare technical documentation, BOMs, and design reports. Collaborate with vendors and suppliers for prototyping and manufacturing feasibility. Support testing, validation, and regulatory documentation for product approvals. Ensure compliance with ISO 13485 and regulatory standards for medical devices.
Posted 1 month ago
7.0 - 14.0 years
8 - 13 Lacs
Bengaluru
Work from Office
At Tenthpin we are seeking talented, client-facing, and collaborative SAP Quality Management (QM)/ Production Planning (PP) Consultants to join our rapidly growing team. The successful applicants will possess strong S/4HANA experience and will have a passion for delivering innovative solutions that add substantial value to our clients, contributing to our reputation as one of the recent success stories within the Management Consulting Industry. The Opportunity As an SAP QM/PP Consultant you will strategically align technology with business objectives. This involves direct collaboration with clients as the client s trusted advisor and oversee the analysis, design, and implementation of technology best practices for effective business solutions. The role will include but not be limited to: Collaborate closely with clients, providing valuable assistance in the implementation of cutting-edge SAP systems. Execute the build, testing, and deployment phases, emphasizing Life Science best practices and innovative customer processes within SAP S/4 HANA environment. Thrive in a diverse environment, seamlessly working within multi-language, multicultural, and multi-disciplinary teams. Exceptional opportunity to further your training with our R&D functions, creating Co-Innovations with leading Lifesciences Organisations to create Industry Leading Products. Actively contribute to your Tenthpin Community, being part of a passionate, like-minded group of consultants, consistently striving to be at the forefront of the industry. You will get to work in an organization that removes the traditional red tape of Consulting, giving you far more time to prioritize your workload, delivering to top-tier clients, and progressing your own career in a positive and empowering environment. Your Experience First and foremost, you are a genuine Management Consultant with exceptional communication skills, the ability to see the bigger picture, and a collaborative approach to creating exceptional solutions. You will also have relevant SAP skills, including: 7 years to 14 years of relevant experience required. At least 2 full project lifecycles as an SAP QM/PP Consultant and experience in S/4HANA is essential. Strong understanding of manufacturing, quality management and production planning processes in SAP QM, including integration with PP module. Proficiency in SAP template design, functional configuration & customization, and adept at providing business consulting services for SAP QM and SAP PP modules. Knowledgeable about SAP integration to LIMS and MES systems as well as interfaces and integration with other SAP modules (MM, PP, PM, EWM). A proven track record in a Big 4 , Major SI , or specialist SAP Consulting Firm would be preferred. Experience in Life Sciences, or process manufacturing industries, particularly in sectors such as pharmaceutical, medical devices, medical manufacturing and chemicals, would be advantageous. Why Tenthpin Tenthpin is a Global Consulting and Technology Boutique for the Life Sciences industry. With around 400 consultants and constantly growing, we currently operate out of 8 countries: Switzerland, Germany, UK, Portugal, Poland, Japan, USA and India. At least sixteen of the top 20 Life Sciences companies worldwide trust Tenthpin for independent and unbiased advice. We offer a competitive salary and benefits package and a collaborative work environment that encourages professional growth and development. Are you passionate about digitally transforming Life Sciences companies? Do you want to create an impact with leading brands and deliver real value? Enjoy working in an entrepreneurial and innovative team? Then we look forward to hearing from you. Tenthpin is an equal opportunities employer.
Posted 1 month ago
5.0 - 9.0 years
6 - 10 Lacs
Hyderabad
Work from Office
Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and align with Amgen s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and alignment to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Involve actively in release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports. Ensure validation strategies meet regulatory requirements and company standards. Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards. Assist with UAT, test data preparation and developing work instructions. Contribute to test automation scripting, framework maintenance, and CI/CD integration. Implement automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines. Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices Ensure timely and effective completion of all validation activities in line with project objectives and schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Find opportunities for process improvements in validation activities. Know the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies. Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Masters degree / Bachelors degree and 5 to 9 years of experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Overall experience in developing, executing and analyzing QA & Test Automation Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Experience with computer system validation and software validation. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com .
Posted 1 month ago
2.0 - 9.0 years
4 - 8 Lacs
Hyderabad
Work from Office
Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose: Post Market Surveillance & Trending group is responsible for conducting science-driven evaluations to assess the safety and quality of Amgen s combination products, medical devices, companion diagnostics, and digital health products. The group is responsible for post market surveillance, product complaints trending and data analytics. Additionally, the group analyses the potential impact of quality issues on patient/user safety across these products. Job Summary: The ISM Engineer is responsible for performing product complaints statistical excursion trending deep dives. Prepares product complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries, as well as generate process metrics to support process surveillance activities. Key Activities: Performs product complaints statistical excursion trending deep dives Understand customer / patient use of Amgen s packaged and/or distributed mechanical and/or electromechanical products Understand manufacturing processes for Amgen s packaged and/or distributed products. Maintain close interaction with multiple functions including Quality (e. g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety s perspectives Prepares and interprets adverse events and product complaints data supporting integrated product surveillance activities Prepares product and process surveillance metrics for internal safety and quality governance forums Pulls complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries Perform data verification of complaints data pulled for inspection requests Applies analytical skills to evaluate complex situations using multiple sources of information Contribute to technology innovation initiatives related to post market surveillance, including AI/ML and automation opportunities Contribute to improvements in trending methodologies and process improvement opportunities Support audits and inspections as appropriate Knowledge and Skills Required Knowledge and Skills: Quality and/or manufacturing experience in biotech or pharmaceutical industry Complaints or complaints trending within a development, manufacturing, or post-market environment Knowledge of product complaints and adverse events intake and processing process Ability to pull and create product complaints and/or adverse events data per request Knowledge of medical devices or combination products, ideally Class II and Class III Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python Preferred Knowledge and Skills: Proven experience with mechanical and/or electromechanical medical devices Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Ability to perform data analysis and derive insights Education & Experience (Preferred) Degree in Engineering or Life Science 5-9 years of quality and/or manufacturing experience as an engineer in the biotech or pharmaceutical industry 2+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III Experience with statistical trending methodology, preferably complaints Strong data analysis experience and a passion for finding correlations across different datasets Experience with data querying and business intelligence tools Strong presentation and teamwork skills What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 1 month ago
2.0 - 9.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose: Post Market Surveillance & Trending group is responsible for conducting science-driven evaluations to assess the safety and quality of Amgen s combination products, medical devices, companion diagnostics, and digital health products. The group is responsible for post market surveillance, product complaints trending and data analytics. Additionally, the group analyses the potential impact of quality issues on patient/user safety across these products. Job Summary: The ISM Engineer is responsible for performing product complaints statistical excursion trending deep dives. Prepares product complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries, as well as generate process metrics to support process surveillance activities. Key Activities: Performs product complaints statistical excursion trending deep dives Understand customer / patient use of Amgen s packaged and/or distributed mechanical and/or electromechanical products Understand manufacturing processes for Amgen s packaged and/or distributed products. Maintain close interaction with multiple functions including Quality (e. g. complaints, device quality, product quality, external supplier quality, manufacturing quality, quality engineering) and contribute to product / device design improvements Collaborate with other safety functions to support integrated surveillance of Amgen products from both quality and safety s perspectives Prepares and interprets adverse events and product complaints data supporting integrated product surveillance activities Prepares product and process surveillance metrics for internal safety and quality governance forums Pulls complaints and/or adverse events data to support ad-hoc analysis and regulatory inquiries Perform data verification of complaints data pulled for inspection requests Applies analytical skills to evaluate complex situations using multiple sources of information Contribute to technology innovation initiatives related to post market surveillance, including AI/ML and automation opportunities Contribute to improvements in trending methodologies and process improvement opportunities Support audits and inspections as appropriate Knowledge and Skills Required Knowledge and Skills: Quality and/or manufacturing experience in biotech or pharmaceutical industry Complaints or complaints trending within a development, manufacturing, or post-market environment Knowledge of product complaints and adverse events intake and processing process Ability to pull and create product complaints and/or adverse events data per request Knowledge of medical devices or combination products, ideally Class II and Class III Data querying skills and experience with data visualizations tools such as Tableau, Power BI, or Python Preferred Knowledge and Skills: Proven experience with mechanical and/or electromechanical medical devices Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Ability to perform data analysis and derive insights Education & Experience (Preferred) Degree in Engineering or Life Science 5-9 years of quality and/or manufacturing experience as an engineer in the biotech or pharmaceutical industry 2+years of experience in complaints or complaints trending within a development, manufacturing or post-market environment, working with medical devices or combination products, ideally Class II and Class III Experience with statistical trending methodology, preferably complaints Strong data analysis experience and a passion for finding correlations across different datasets Experience with data querying and business intelligence tools Strong presentation and teamwork skills What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 1 month ago
8.0 - 13.0 years
12 - 16 Lacs
Hyderabad
Work from Office
Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lie within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Group Purpose Integrated Signal Management group is responsible for the direction and strategy for safety signal detection and management, safety governance, and quality complaints trending and analytics. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking, product complaints trending and analytics; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics. Job Summary The Innovation Specialist will serve as a key strategic partner within the Signal Management and Post-Market Surveillance & Trending organization, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with the ISM Data Science team. This role will bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products. Key Activities Technology Scouting & Evaluation - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance. Collaboration & Innovation Development - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment Engage with stakeholders (e. g. , TA Safety) to identify unmet needs and prioritize use cases. Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives. Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products. Perform regulatory impact and risk analysis of proposed solutions Develop internal guidelines and documentation for use of advanced analytics in surveillance activities. Project Execution - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. Translate business needs into functional requirements for solution development. Track project progress, manage risks, and report findings to senior leadership. Knowledge and Skills Required Knowledge and Skills: Experience in post-market surveillance, pharmacovigilance, medical device vigilance, or related domain Knowledge of combination products and medical devices, including device safety monitoring regulations and standards Knowledge of software development concepts Experience with market scanning, vendor/product evaluation Knowledge of regulatory framework and guidance of principles for AI in the medicinal product lifecycle Preferred Knowledge and Skills: Demonstrated experience working with or evaluating AI/ML tools, safety analytics, natural language processing (NLP), or data mining. Strong project management, cross-functional collaboration, and communication skills Education & Experience 8-13 years of industry experience Experience with market scanning, vendor/product evaluation Experience working with AI/ML and/or automation tools Strong project management, cross-functional collaboration, and communication skills What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .
Posted 1 month ago
2.0 - 6.0 years
1 - 5 Lacs
Hyderabad
Work from Office
Career Category Quality Job Description Let s do this. Let s change the world. In this vital role you will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities: The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta. Develop and maintain comprehensive test plans for 3DExperience platform modules and application Contribute actively to release planning and estimate test efforts Test in an Agile development environment, analyze and communicate test results to team and manager Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), Validation Reports, deviations, change control, and non-conformance management. Assist with UAT, test data preparation and developing work instructions. Develop and execute automated test suites across various modules in 3DEXPERIENCE. Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis. Collaborate with cross-functional teams, including quality assurance, product owners, business owners to execute validation activities and meet project deadlines. Work closely with manager to ensure timely and effective completion of all validation activities in line with project objectives and schedules. Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies. Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Bachelor s degree and 2 to 6 years experience in Software Quality and GMP Validation Preferred Qualifications: Functional Skills: Must-Have Skills: Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions. Experience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc. ). Overall experience in developing, executing and analyzing QA & Test Automation Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation. Experience with computer system validation and software validation. Strong problem-solving and analytical skills. Good-to-Have Skills: Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable Experience with automated and computer-controlled systems validation (21 CFR Part 11) Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Ability to learn quickly, be organized and detail oriented. Strong presentation and public speaking skills. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com .
Posted 1 month ago
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