95 Iso 13485 Jobs - Page 3

What if the work you did every day could impact the lives of people you knowOr all of humanity At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary: This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina s compliance with the Quality System Regulations, Illumina s Quality policies, FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. Participates in continuous improvement activities of Illumina s suppliers, purchased parts and purchasing controls. Responsibilities: Responsible in qualification, evaluation and monitoring activities of new suppliers and partners for Illumina products and outsourced services Collaborates with cross-functional subject matter experts to coach and represent partner and service supplier processes. Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products Drives process, quality and product improvements through supplier and partner development activities, risk management, identification and resolution of current and potential issues Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for Service Supplier, Partner Development, and Product Quality Leads and facilitates Quality Investigations and CAPA/SCARs to resolve Quality issues with Service Supplier and Partner, ensuring mitigations, containment and corrective actions are implemented in a timely manner Leads supplier/partner audits to drive process standardization and continuous improvement, including audit action timely resolution and closure. Support Global team initiatives including supplier/partner performance reviews, corporate and site Quality Management Reviews and more. Supports regional initiatives associated with Service Supplier and Channel Partner process improvements and issue resolution. Make recommendations, and drive programs to improve channel partners and service supplier performance Reviews non-conformance, Quality Investigations, Complaints and CAPA reports to identify actions needed to track and improve program health by site or globally. Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications Ability to provide training to other team members to ensure consistency and compliance to processes and procedures. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements: Experience collaborating with cross-functional product development and operational teams (Global HQ teams and local/regional teams) Strong QMS auditing (ISO 13485, ISO 9001, ISO 17025) experience Strong communication, presentation and negotiation skills Working knowledge and experience with Quality Management Systems, Project Management, and Process Engineering methodologies and tools Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities. Demonstrated capability in successfully managing and leading change Practice identifying, mitigating, and resolving risks Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments. Experience with electronic product life cycle (PLM) systems such as EtQ, SAP or other PLM systems. Practical experience in FDA and ISO regulated environments is a plus Experience with statistical analysis Ability to travel domestically and internationally as needed. Estimate 25% of the time. Ability to work PST hours to collaborate with teams in HQ in San Diego All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. Experience/Education: BS or equivalent in a technical discipline with 5+ years of experience. MS in a technical discipline with 3+ years of experience. PHD in a technical discipline with 1-3 years of experience. Experience working in a regulated environment, in-vitro diagnostics preferred. Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.

Job Description for the Role of Compliance and Audit Executive (Medical Devices ) Location: Ambarnath Band: 5B Salary: 30K to 50K Responsibilities: 1.Collaborate with various departments to ensure compliance with MDR(India) 2017, EUMDR 2017/745, ISO 13485:2016, ISO 9001:2015 and another relevant applicable regulatory requirement as and when enforced / implemented. 2.Review and improve existing SOP, Work Instructions, Policies and QMS Forms across departments to comply the above said standards. 3.Preparation and Compilation of Technical documents/Device Master File according to the above said standards. 4.Strong understanding in performing Risk Management Process as per ISO 14971. 5.Good Knowledge in conducting Process Validation, Design Control and Software Verification and Validation activities. 6.Governing the import, manufacture, distribution, and sale of medical devices in India. 7.Conduct internal audit and to support external audit to ensure the compliance with the applicable standards. 8.Able to handle post-market surveillance and complaint handling process. 9.Understand RCA techniques and perform CAPA as and when required. Education and Experience: 1. Bachelors degree in a relevant field such as Science/Engineering Biomedical, Electronics, Mechanical etc. 2. Individuals with up to 2+ years of experience in regulatory compliance or medical device industry are welcome to apply. 3. Having certificate of ISO 13485 Internal Auditor / Lead Auditor is added advantage. 4. Strong analytical skills and the ability to interpret complex regulatory information. 5. High IQ with a demonstrated aptitude for understanding and applying regulatory standards.

What if the work you did every day could impact the lives of people you knowOr all of humanity At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. Position Summary: This position is responsible for Supplier Quality activities that improve, monitor and measure Illumina s compliance with the Quality System Regulations, Illumina s Quality policies, FDA regulations and ISO standards as well as Illumina product quality requirements for current operational objectives. Participates in continuous improvement activities of Illumina s suppliers, purchased parts and purchasing controls. Responsibilities: Responsible in qualification, evaluation and monitoring activities of new suppliers and partners for Illumina products and outsourced services Collaborates with cross-functional subject matter experts to coach and represent partner and service supplier processes. Participate as a core/extended Quality team member of new product development and sustaining teams to assure processes are in place to design and release highly reliable and safe products Drives process, quality and product improvements through supplier and partner development activities, risk management, identification and resolution of current and potential issues Responsible for updates to purchasing control procedures and processes as needed to stay compliant to quality system requirements and regulations. Provides Quality Assurance expertise and guidance for Service Supplier, Partner Development, and Product Quality Leads and facilitates Quality Investigations and CAPA/SCARs to resolve Quality issues with Service Supplier and Partner, ensuring mitigations, containment and corrective actions are implemented in a timely manner Leads supplier/partner audits to drive process standardization and continuous improvement, including audit action timely resolution and closure. Support Global team initiatives including supplier/partner performance reviews, corporate and site Quality Management Reviews and more. Supports regional initiatives associated with Service Supplier and Channel Partner process improvements and issue resolution. Make recommendations, and drive programs to improve channel partners and service supplier performance Reviews non-conformance, Quality Investigations, Complaints and CAPA reports to identify actions needed to track and improve program health by site or globally. Works with strategic partners and suppliers to ensure global awareness and compliance to procedures and specifications Ability to provide training to other team members to ensure consistency and compliance to processes and procedures. Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Requirements: Experience collaborating with cross-functional product development and operational teams (Global HQ teams and local/regional teams) Strong QMS auditing (ISO 13485, ISO 9001, ISO 17025) experience Strong communication, presentation and negotiation skills Working knowledge and experience with Quality Management Systems, Project Management, and Process Engineering methodologies and tools Experience with Non-conformance Handling, Failure Investigation (CAPA/SCAR) and Risk Management (FMEA) activities. Demonstrated capability in successfully managing and leading change Practice identifying, mitigating, and resolving risks Ability to work effectively in a fast-paced, dynamic environment with shifting and competing priorities Demonstrated experience in Supplier Quality and Management activities such as component qualification, audits, risk assessments. Experience with electronic product life cycle (PLM) systems such as EtQ, SAP or other PLM systems. Practical experience in FDA and ISO regulated environments is a plus Experience with statistical analysis Ability to travel domestically and internationally as needed. Estimate 25% of the time. Ability to work PST hours to collaborate with teams in HQ in San Diego Experience/Education: BS or equivalent in a technical discipline with 5+ years of experience. MS in a technical discipline with 3+ years of experience. PHD in a technical discipline with 1-3 years of experience. Experience working in a regulated environment, in-vitro diagnostics preferred.

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters. A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others. Required Qualifications This role requires 3 plus years of experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college. Desired Characteristics Basic experience with ISO 13485 standard and Medical device regulations. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. 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 Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https: / / www.ge.com / careers / fraud #LI-MA6 Additional Information Relocation Assistance Provided: No

Additional Locations: India-Haryana, Gurgaon Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Responsible for providing mechanical engineering support in the maintenance of project DHF deliverables in Requirements Management (RM) tool for new and sustaining medical device products (invasive and non-invasive). Key Responsibilities: Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization s QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Qualifications: Mechanical Engineering ( B. E. /B. Tech) with 8-10 years of experience. Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit. Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools. Willingness to work in an agile environment. Requisition ID: 596291 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

We have opening for a couple of internships available with our Regulatory Information and Facilitation Center(RIFC ). RIFC aims to assist bio-entrepreneurs/MedTech Startups in planning, seeking and securing regulatory approvals. We plan to achieve this by providing information in an entrepreneur-friendly manner, providing access to experts and regulators, providing access to practical insights from other entrepreneurs, providing services and organizing relevant and useful events. Position 1 - Food Regulatory Services Job Description Assist to design and operate a regulatory advisory service for start ups. Support in Food certification like FSSAI, food regulations in India compliant format and providing consultative advice on gap closure. Provide technical support for assigned clients and tasks. Activities to include function mentioned below but not limited to; Quality Assurance, Regulatory Affairs, Risk Management, Standards interpretation, Design Documentation for new product development and remediation of existing products. Develop capabilities and resources to provide guidance for regulatory requirements and certifications for food products. Develop database for Food Safety and Standards Regulations and Food safety compliant system (FoSCoS) Work closely with experts, regulators etc to offer high quality advice Create mechanisms to provide different certification services as and when necessary Support for the new projects in the field of regulatory science practices, database generation, white papers, articles, blogs, etc. Assist to conduct workshops and trainings to familiarize start ups/ technology developers/entrepreneurs to regulatory requirements for their products Candidate Profile Bachelor/ Master s degree in Food Science, Food Technology, or related field. Masters degree preferred. Good communication skills Position 2 - Regulatory Affairs > Position Filled Job Description Assist to operate a regulatory advisory service for start ups. Support in MDR 2017, India, EU MDR, IVDR & 21 CFR USFDA compliant format and providing consultative advice on gap closure. Provide technical support for assigned clients and tasks. Activities to include function mentioned below but not limited to; Quality Assurance, Regulatory Affairs, Risk Management, Standards interpretation, Design Documentation for new product development and remediation of existing products. Develop capabilities and resources to provide guidance for regulatory requirements and certifications for medical devices, food and agriculture products Work closely with experts, regulators etc to offer high quality advice Create mechanisms to provide different certification services as and when necessary Support for the new projects in the field of regulatory science practices, database generation, white papers, articles, blogs, etc. Undertake hands on regulatory support activities by maintaining a versatile clean manufacturing facility for start up Assist in Clean Room development and ISO 13485 QMS for the same Maintain and update the RIFC website Assist to conduct workshops and trainings to familiarize start ups/ technology developers/entrepreneurs to regulatory requirements for their products Candidate Profile Biomedical Engineer, Masters in Pharmacy Quality Assurance Techniques/ Regulatory Affairs. Good communication skill.

Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence. Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. Do you want to work in ManufacturingDo you enjoy being responsible to support for batch manufacturing activities and On Time Delivery to CustomerThen read on! We are currently seeking an Advance Technician Production Operations who will be responsible for supporting in manufacturing day-to-day activities in Dispensing/Packaging/Labeling. Candidate must be able to manage team or supervise their down line to ensure meeting daily output. The company is compliant with ISO 9001: 2015, ISO 13485: 2016 EN ISO 13485: 2016, MDSAP and Beckman Coulter corporate Quality system requirements. In this role, you will be responsible for: Understand the process for labeling, Dispensing Packaging and responsible to handle unit operation of Packaging instruments. Responsible to meet the FPY and OTD Targets for production as per planning schedule. Escalation to respective supervisor in case if any downtime or issues in line. Meet regulatory requirements and follow internal company policies, SOPs, good understanding in GDP, cGMP requirements. Able to manage up to 12 staffs for labelling and packaging. Must have good communication and be able to support in urgent countermeasures for day-to-day issues occurred at Gemba and keep up to date to all Associates during Daily Management. Candidate should be able to take ownership for his own KPI and get it tracked by day-to-day to achieve the daily target. Support for On Time delivery to the customer. The required qualifications for the job include: M.Sc. with 4-6 years of experience. We offer comprehensive package of benefits including paid time off, medical insurance to eligible employees. Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com . At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Impacts quality of own work and the work of others on the team. Focused on execution of standard enabling activities/provision of advice subject to policy and work routines within an enabling discipline. There may be some latitude to rearrange the sequence to complete task/duties based on changing situations. Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Broadening knowledge of theories, practices and procedures in own discipline to execute functional policy/strategy; still developing functional knowledge and skills. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. May have some autonomy to make decisions within a defined framework. Resolves issues in situations that require good knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined policy/parameters. A job at this level requires good interpersonal skills. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Explains technical information to others. Required Qualifications This role requires basic experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college. Knowledge of ISO 13485 and medical device regulations for eg 21 CFR and EU MDR Desired Characteristics Basic experience in ISO 13485 quality management standards and medical device regulations Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. 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 Additional Information Relocation Assistance Provided: No

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Sr. Quality Engineer for PVH OU to support critical PSURs A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices. Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices. Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities. Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance. Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR. Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on EU MDR. Previous experience working in a cross-functional team environment. Hands-on experience on Risk Management, Design Controls for Medical Devices. Participate when appropriate in audits. Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards. Experience in collaborating with regulatory affairs teams for submission of safety reports. Minimum Qualification B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Key Technical Competencies Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Fair Knowledge in post market surveillance Familiar with DMAIC or DMADV(DFSS) methodologies Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Sr. Quality Engineer for NMPH risk management activities A Day in the Life Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, DFMEA, and risk management report, adhering to ISO 14971 standards. Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices. Must Have Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements. Subject matter expert in risk management for designated medical device products or platforms. Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes. Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements. Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies. Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator. Provide Quality support to facilitate resolution of product complaints and/or safety issues Previous experience working in a cross-functional team environment. Familiar with statistical software tools (Minitab) Develop templates and trainings based on the quality system regulations, applicable standards and guidance. Independently review all deliverables to ensure compliance with development process and the standard. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices. Minimum Qualification B E or B.Tech in Mechanical/Biomedical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Key Technical Competencies Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Good verbal and written communication skills Fair Knowledge in post market surveillance Familiar with DMAIC or DMADV(DFSS) methodologies Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Cerification ISO 13485 Internal Auditor / Lead Auditor Cerification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Work Flexibility: Not available What you will do: Oversee PLCM checklist management, ensuring accountability for obsolescence processes and Product Lifecycle transitions Identify and drive SKU rationalization strategies by analyzing low-performing products based on margin, revenue, and volume Serve as the primary liaison between cross-functional teams, Integrated Business Planning, and the PLCM group. Partner with global teams, including Divisional DOLs, Planning COE, and PLCM leaders, to enhance and standardize planning processes. Contribute to value improvement and design optimization activities. What You need: Preferred experience (Strongly desired): Understanding of Lean Manufacturing, Process Excellence/Six Sigma tools Product Lifecycle & Disposition Management - Hands-on experience in PLCM, obsolescence planning, product retirements, and supply chain impact analysis. Change & Quality Management - Expertise in ECN/ECR, CAPA, Non-Conformance (NC), and Quality Management Systems (QMS) in a regulated environment. Regulatory & Compliance Knowledge - Familiarity with FDA, EU MDR, ISO 13485 and experience managing design history files (DHF), risk management, and regulatory submissions. Medical Device Design control and Sustenance activities experience preferred. Strong communication skills in English, both written and verbal. Minimum Qualifications (Required): Bachelors/Masters in Mechanical, Electronics, or Mechatronics Engineering 8-11 years of relevant work experience Travel Percentage: None

1. Experience in manufacturing operations 2. 6+ years experience in a supervisory capacity and leadership roles 3. Bachelors degree in production management, Engineering, or a related field. 4. Excellent project management skills 5. Experience in creating procedures and monitoring product servicing activities 6. Experience in production and quality control as per ISO 13485 7. Decent understanding of medical device manufacturing processes 8. Proven track record of successfully training employees in productivity and safety 9. Ability to coach and mentor employees on a one-on-one basis as well as a group 10. Knowledge of project management principles and practices 11. Knowledge of business and management principles and practices

Beckman Coulter LS Beckman Coulter Life Sciences mission is to empower those seeking answers to life s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you ll help drive our vision of accelerating answers and our commitment to excellence. Beckman Coulter Life Sciences is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. This role will be an On-site role at our Beckman Coulter Life Science, Bangalore Development Center (BDC) manufacturing facility located in Bengaluru. Do you want to work in Manufacturing Operations TeamDo you enjoy working in a dynamic work force, collaborating with other team members and diverse groups, to meet Organization goal and customer demandThen read on! We are currently seeking a "Polymer Chemist I" position in Production-Operations who will be primarily responsible for polymer dye synthesis and related manufacturing processes. The company is compliant with ISO 9001: 2015, ISO 13485: 2016 EN ISO 13485: 2016, MDSAP and Beckman Coulter corporate Quality system requirements. In this role, you will be responsible for: Handing metal catalyst reactions. Performing and optimization of C-N and C-C coupling reactions. Experience in handling air/moisture sensitive reagents and performing of reactions at the temperature range of -78 C to higher temperatures. Perform purification of the organic compounds using different types of column chromatography techniques and other separation techniques. Responsible for organic synthesis of fluorescent dyes suitable for Flow Cytometry applications. The required qualifications for the job include: M.Sc. in Chemistry/Organic Chemistry/Biochemistry or related discipline. Experience: 3-5 years Demonstrate ability to be flexible and resourceful. Ability to work in a team environment Excellent communication skill. It would be a plus if you also possess previous experience in: Having polymer chemistry and Conjugation chemistry knowledge with good Hands-on experience on HPLC / UPLC / GPC / TFF / Spectrophotometer / Fluorimeter and Automated purification system. This job is eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical insurance to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Company s sole discretion, consistent with the law Join our winning team today. Together, we ll accelerate the real-life impact of tomorrow s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com .

Job Descriptions : Familiarized with: ISO 9001-2015 AS91100 - Aerospace EN15085 - Pressure Vessels ISO 14000 - Enviornment ISO 13485 - Medical instruments NADCAP Specific to sheet metal manufacturing industry. Implement necessary standards and upgrade as and when required as well as identify new standards for the organization. Ability to manage independently quality team and develop skillset including problem-solving, Kaizen and customer interaction. Identify areas of improvement on a continuous basis and make effective reports, statistics of the quality department objectives, and performance metrics. Should demonstrate problem-solving capabilities and ability to address crisis/critical issues. Familiarized with QMS System, Vendor audit, internal audit, and supplier development. Work with other departments and ensure quality systems. Communication skill Leadership skill Problem-solving skill Customer Focus

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Purpose Statement Responsible for providing mechanical engineering support in the maintenance of project DHF deliverables in Requirements Management (RM) tool for new and sustaining medical device products (invasive and non-invasive). Key Responsibilities Read and interpret technical drawings, procedures, and protocols. Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining. Investigates and evaluates the compliance requirements driven from organization s QMS/Work Instructions and validate the same in templates developed in RM tool. Investigates and evaluates existing RM tools/technologies - JAMA, Polarion etc. Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents. Performs validation of patches and versions of RM tool as and when available. Support multiple projects across different time zones - Asia, Ireland, and North America Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable: Assures that appropriate resources (personnel, tools, etc. ) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System. Qualifications Mechanical Engineering ( B. E. /B. Tech) with 8-10 years of Exp Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971 Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit Knowledge of MS Office Tools - Word, Excel, PowerPoint. Strong attention to detail with good communication skills. Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making. Ability to collaborate and work as a team player. Nice to have experience in product lifecycle management software and tools. Willingness to work in an agile environment. Job Scope and Leveling Guidelines Functional Knowledge Requires solid knowledge of conceptual and technical and/or functional knowledge and procedures within own job function and a basic understanding of these elements in related job functions. Business Expertise Applies understanding of business drivers and how own team integrates with others to accomplish own work. Leadership No supervisory responsibility; may provide informal guidance to new team members Problem Solving Solves problems considering common practice or procedures; determines appropriate action by analyzing possible solutions and their impact on the business or technology using practical experience, judgment and precedents. Works under general direction from more senior level roles/manager Impact Impacts quality of own work and the work of others on the team; works within guidelines and policies. Interactions (and Communications) Explains factual, sometimes complex and potentially dynamic information to others in straightforward situations. Organizes and presents data/ information to influence decision making, primarily to internal audiences. Requisition ID: 602796 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Job Summary: We are seeking a skilled Electronics R&D Engineer to join our team focused on the development of innovative medical devices. The ideal candidate will have hands-on experience in electronic testing and a strong background in converting electronic designs into manufacturable products. Key Responsibilities: Design and Development: Create and develop electronic systems and components for medical devices, ensuring they meet specified requirements. Prototyping and Testing: Build prototypes, conduct rigorous testing, and validate designs to ensure functionality and compliance with industry standards. Manufacturing Transition: Collaborate with manufacturing teams to convert existing electronic designs into production-ready formats, including assembly instructions. Documentation: Write detailed protocols, test plans, and populate test results to support regulatory submissions. Regulatory Compliance: Ensure designs adhere to IEC 60601 standards and ISO 13485 quality management systems. Cross-Functional Collaboration: Work closely with cross-functional teams, including hardware, software, and quality assurance, to define project requirements and solve technical challenges. Qualifications: Education: Bachelors degree in Electronics Engineering / Electrical Engineering. Experience: 4-6 years of relevant experience in electronics design and development, specifically within the medical devices sector. Technical Skills: Proficient in eCAD software for circuit design (e.g., Orcad / Mentor Graphics). Hands-on experience with electronic testing equipment and techniques. Strong understanding of electronic circuits and components. Well versed with obsolescence mgmt. Regulatory Knowledge: Familiarity with IEC 60601 standards and ISO 13485 requirements is essential. Communication Skills: Excellent verbal and written communication skills; ability to document processes clearly for regulatory submissions. Must Skills: Experience in hardware prototyping techniques. Assembly & Testing of complete unit / device. Ability to manage documentation needs for regulatory submissions effectively. Strong analytical skills with attention to detail in problem-solving.

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines. Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues. Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.). Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions. Required Qualifications This role requires advanced experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college with minimum of 8 years of experience in healthcare domain. Desired Characteristics Advance knowledge on ISO 13485 and Medical device regulations and standards for MDSAP countries for eg. FDA 21 CFR, EU MDR. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity. 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 . Additional Information Relocation Assistance Provided: Yes

Mandatory Skills :- Risk Management. ISO 14971, FDA CFR 820, ISO 13485, Risk Mitigation, Medical Devices. Location : Bangalore Notice period : Immediate to 45 days. Skill Sets: 1. 7-12 years working experience in a regulated industry specially as a medical device of relevant experience in medical device risk management. 2. Knowledge in ISO 13485, ISO 14971, FDA CFR 820 3. Medical Device Risk analysis, risk evaluation, risk control, Risk mitigation implementation 4. Good written and verbal communication in English language 5. Strong interpersonal skills 6. Knowledge and understanding of international safety standards for medical devices 7. Related experience with Medical Device Risk analysis and Cybersecurity Risk management Responsibilities: 1. Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio. 2. Knowledge of remediation of risk files as per ISO 14971:2019. 3. Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix. 4. Lead issue impacts assessments to calculate risks associated with defects and complaint records. 5. Collaborates as risk management subject matter expert with development teams to ensure the comprehensive implementation of risk control measures are compliant to local requirements as and international standard ISO 14971 6. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams. Additional Advantage: Good knowledge of SDLC (IEC-62304) and SaMD .

Regulatory Strategy & Compliance US, FDA, MDR Documentation & Submissions Regulatory Monitoring/ Reporting, Submission of UDI to GUDID/EUDAMED Regulatory Audits and Inspections CAPAs, NCs closure Navigating regulatory requirement for CDSCO, US FDA Required Candidate profile BE/BTech- Mech. min. 3+ years of exp. in regulatory affairs with medical device industry, strong understanding of U.S. FDA and European regulatory requirements, EU MDR 2017, ISO 13485, RAC, CDSCO.

Job : System Verification Engineer Location: Bengaluru Experience: 8 + Years Qualifications Create clear product design documentation such as concept diagrams, specifications, requirements, test plans, and V&V reports perform test/verification for NPI or sustaining of innovative electromechanical products Establish and maintain traceability between requirements, and testing Develop test protocols for the purposes of design verification and validation Execute testing and generate associated reports Oversee the building and testing of prototypes, including internal team and external vendor management Performs hands-on system testing and troubleshooting of technical issues Design benchtop tests, fixtures, and regression test plans to prove out concepts, functionality, and safety Required Qualification Bachelors degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field. 8+ years experience in electromechanical device and system design/verification for new product development Direct hands-on systems engineering experience, preferably with medical device electronic systems or other complex electronic hardware. Technical competencies: Experience developing software driven electromechanical devices in a regulated environment. Broad engineering expertise across all engineering disciplines. Direct experience in requirements authoring, decomposition, analysis, traceability, and verification. Direct experience with complex electronics systems/component design. Experience in writing detailed product Verification/qualification plans and reports. Experience with integrated systems verification, including developing hardware verification test plans and verification test reports. Previous experience with change management Hands-on experience building, testing, and troubleshooting prototype devices Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities, and challenge. Preferred Qualifications Familiarity with all phases of the product development lifecycle. Familiarity with HW / Embedded SW development, integration, and verification Familiarity with scripting and data analysis experience using Python, MATLAB, or equivalent programming languages. Experience working with 3D design tool, Creo , Solid works , Fusion 3Detc. Experience with low fidelity prototyping 3d Printing, PCB design, PCB reworks etc. Experience in the medical device industry, ISO 13845 , FDA quality management system Enjoy working effectively as part of a small, fast-paced, cross-functional, cross-cultural integrated team.

Sr Manager - Quality Location: Cochin Experience: 15-20 years Qualification: BTech/MTech in any Discipline Key Responsibilities: Lead and manage the Quality Assurance function within the R&D environment, ensuring high standards of quality for electromechanical products. Oversee the implementation and maintenance of Quality Management Systems (QMS) in compliance with ISO 9001, AS 9100, TS 16949, ISO 13485 standards. Act as the management representative for QMS, ensuring alignment with organizational goals and regulatory requirements. Conduct and lead internal and external audits, ensuring continuous improvement across R&D processes. Develop and maintain quality processes, documentation, and audits to ensure product and process quality in R&D. Key Requirements: 15-20 years of experience in Quality Assurance, with a strong background in R&D environments (preferably electromechanical products). Proven experience in QMS standards, including ISO 9001, AS 9100, TS 16949, and ISO 13485. Lead Auditor/Internal Auditor Certification. Experience as a Management Representative for QMS. Strong leadership and communication skills to drive quality initiatives and audits within the R&D team. Preferred Skills: Experience in electromechanical product development and quality assurance in R&D environments.

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. Job Description Roles and Responsibilities GEHC ONLY Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms. Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy. A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. Possesses knowledge on QMS parameters with respect to ISO 13485 standards, including but not limited to, prior experience in handling Non-conformances, CAPA, Concessions and Deviations. In-depth and hands-on knowledge on process risk assessment and risk management with respect to ISO 14971 will be a key responsibility. Understands the process principles and drives the establishing, monitoring, and maintenance of all key performance indicators for product and process quality, with the support of cross functional teams for ongoing projects and new projects Demonstrate knowledge on Medical devices Refurbishment, Repairs and Harvesting. Required Qualifications For roles outside of the USA- This role requires advanced experience in the Quality Healthcare Quality. Knowledge level is comparable to a Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience). For roles in USA - Bachelors degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)). Knowledge of standard and Regulations like ISO 13485, ISO 14971. Experienced with both Internal and External Audits in both Auditor and Auditee roles. Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

Position: Computer System Validation Engineer Experience: 5+ years Location: Anywhere in India Mandates: Computer System Validation (CSV) Requires Competences: Domain specific competencies preferably Supply chain domain. Knowledge on Statutory requirements for the role like FDA, Sox, etc. Strong Interpersonal skills Strong knowledge in FDA E2E Validation, GAMP 5, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 11 Expertise in validation of enterprise-wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines. Experience and Background: Domain or related IT experience of 5-8 Years Worked in software development implementation projects as a validation Engineer in multiple global software development implementation projects. Certified in ITIL / ISTQB (foundation) or good understanding in Change management or flows Experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry CSA experience is an added advantage. Education: Bachelor s degree or Master s degree (In Science, Pharmaceutical, Biotechnology or lifescience) About the Client: The client is an Indian multinational corporation that provides information technology, consultant and business process services. It is one of the leading Big Tech companies.

Additional Locations: India-Maharashtra, Pune Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we ll give you the opportunity to harness all that s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we ll help you in advancing your skills and career. Here, you ll be supported in progressing - whatever your ambitions. Manager for multiple product development and technology development projects. Provide technical leadership, management responsibility for product design and identification of new technology opportunities. Devotes a significant portion of their time to managerial, leadership, organization and staff development responsibilities: Key Responsibilities: Drives functional excellence initiatives, delivers high quality RD functional. Deliverables, and ensures technical excellence for product or technology development. Drives technical projects of major magnitude and scope. Provides significant guidance and approval regarding technical strategies and approaches. Ensures continued intellectual property development from self and staff. Owns intellectual property development for the product line and technologies. Provides guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high-quality staff. Develops and monitors department budgets Determines appropriate staff levels, schedules and resources. Co-ordinates sessions with project managers/core team leaders to look for opportunities for staff to learn about new initiatives or volunteer on new projects. Drives the development of department tools and methodologies. Determines project staff assignments and schedules work to meet completion dates and RD deliverables. Establishes cross-functional team relationships. Provides an overview of the function and role of his/her group, technical skill sets. Requirement: B.E./ B. Tech or Master in Engineering or Science Minimum 15 + years of experience in System Verification 5+ years of experience with Test automation Medical device development verification experience is preferred Experiences working with ISO 13485, IEC 62304 or any other regulatory environment is preferred Requisition ID: 596590 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn t just business, it s personal. And if you re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

The Senior Systems Engineer is responsible for the risk management (RM), design and requirements specification, usability engineering, and compliance engineering of medical electrical systems used in Neurology, Audiology, and Newborn Care products. You can expect to be involved in all phases of the product lifecycle, for both new product introductions and maintenance of existing products. This role entails a special focus on RM for post-market activities. In this job, you will: Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers Execute risk analysis activities using FTAs, FMEAs and similar tools Analyze production and post-market data to identify changes to product risk Apply ISO 13485, ISO 14971, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to systems engineering group Participate in developing design controls procedures for application to legacy products and new product development Identify and maintain traceability between risk control measures and product requirements and verification / validation Take guidance from the lead risk management engineer for risk management responsibilities and improvements Coordinate activities with contributors from regulatory and quality affairs, clinical, marketing, and cross-functional engineering disciplines Participate in quality improvement, complaints investigation, change control, and safety assessment processes Contribute to harmonizing the company s various medical device platforms by converging system architecture and reusing components as well as design and test practices (product line engineering), specifically related to risk analysis Travel: up to 25% domestic or international travel Qualifications: Bachelor s degree in Engineering or Science; Master s degree is an asset Minimum 7 years systems engineering relevant experience and/or training 5+ years experience in the medical device industry working with applicable quality and safety standards, and regulations Experience with risk management process and tools; requirements specification and traceability Experience with CAPAs and DHF remediation for legacy products Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments Experience with project management a plus.