28 Design Control Jobs

As a Senior Analyst in R&D Compliance Specification at Kimberly-Clark, you are a dedicated learner and a natural leader who takes initiative to improve processes and engage others in the journey. Your commitment to integrity and quality is unwavering, ensuring that your responsibilities contribute to long-term success. By joining our team, you will play a crucial role in enhancing healthcare for billions of individuals worldwide, starting with your efforts. Reporting to the R&D Center of Excellence Leader, you will be an integral part of the EM R&D Team. Your main responsibility will be to ensure that all products and processes adhere to regulatory standards and internal specifications. This entails developing, implementing, and maintaining compliance programs while managing product specifications to uphold quality and consistency within the Kimberly-Clark Quality Management System. Your role is vital in supporting business objectives and embodying the One K-C Behaviors and values. Key responsibilities include developing and implementing compliance programs to meet regulatory requirements, overseeing design control activities to ensure products align with regulatory and quality standards, managing change control processes, harmonizing procedures to promote efficiency, monitoring internal processes for compliance, and maintaining product specifications. Additionally, you will collaborate with cross-functional teams, conduct training sessions on compliance practices, stay updated on regulatory changes, prepare compliance reports, investigate issues, and support audits. In this role, you will act as a liaison between the R&D and Quality departments, collaborate with Quality Assurance teams, conduct training sessions, and facilitate process harmonization initiatives. You will also be responsible for monitoring internal processes to ensure compliance with industry standards and regulations. Your ability to build collaborative relationships, drive solutions, and maintain integrity in all communications is essential to succeed in this position. Based in Ho Chi Minh City, Vietnam, you will work in manufacturing facilities, where you may be exposed to various environmental conditions. Proper personal protective equipment must be worn at all times to ensure safety. Your commitment to self-development, collaboration, and integrity will be key to thriving in this dynamic role. To qualify for this position, you should hold a Bachelor's degree in a relevant scientific field and have at least 3 years of experience in compliance management, quality assurance, or a related field. Strong knowledge of regulatory requirements, attention to detail, organizational skills, analytical abilities, effective communication, and proficiency in compliance management tools are essential skills for success in this role. At Kimberly-Clark, we offer a range of benefits to support your health, well-being, and professional development. From medical, dental, and vision coverage to flexible savings accounts and diverse income protection options, we prioritize your holistic well-being. Additionally, we provide support for educational pursuits, childcare, and other personal needs to ensure a fulfilling work experience. If you are ready to contribute to a global leader in healthcare and consumer products, click the Apply button to start the application process. We look forward to reviewing your qualifications and exploring the potential fit for this role. For more information about careers at Kimberly-Clark, visit our website. In conclusion, this role offers you the opportunity to be part of a team dedicated to innovation, growth, and impact. With a focus on sustainability, inclusion, and career development, Kimberly-Clark provides a supportive environment where you can make a meaningful difference in the world. Join us on this exciting journey of purpose-driven performance and growth.,

Job Summary: We are seeking for a highly motivated Associate to join the Design Control team. The ideal candidate will have experience in Design Control and Risk Management of Medical Devices, proficiency with Teamcenter PLM or similar product lifecycle management tools and with Polarion or similar requirements management tools. This role will play an important role in transforming and uplifting Design History Files to Teamcenter PLM and maintaining DHF documentation in the PLM system. Key Responsibilities: Plan and execute the migration of Design History Files from the current systems to Teamcenter PLM. Develop and maintain Design Control and Risk Management documentation in the PLM system. Collaborate with cross-functional teams to ensure seamless implementation of Teamcenter PLM into the organization. Provide support and/or training to team members on the use of digitized tools and processes. Utilize Polarion requirements management tools to manage and track requirements. Ensure compliance with Design Control regulations and standards for medical devices. Identify and implement process improvements to enhance efficiency and compliance. Qualifications: Bachelors degree in engineering, or a related field. Minimum of 2 5 years of experience in Design Control of Medical Devices (e.g., electromechanical, optical, SiMD/SaMD, combination products). Proficiency with Teamcenter PLM or similar product lifecycle management tools. Preferred: Experience with Polarion or similar requirements management tools. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Ability to work independently, proactively identify issues, recommend and implement solutions, and deliver quality results on schedule while managing multiple tasks and customers. Detail-oriented with a commitment to quality and compliance. Knowledge, Skills And Abilities Personal Effectiveness Competencies: Project Excellence - Intermediate Continuous Learning - Intermediate Digital and Technology Savvy - Intermediate Operational Excellence - Intermediate Breakthrough Analysis - Intermediate Organizational Savvy - Fundamental Skills and Knowledge: Design Control and Risk Management STEAM Applied Science, Technology, Engineering, Arts and Math Regulations and Guidelines Proficiency with Teamcenter PLM or similar product lifecycle management tools Preferred: Polarion or similar requirements management tools Microsoft Office suite (i.e., Word, Excel, PowerPoint, Visio) Technical/Scientific Writing in English in a regulated environment Verbal English communication skill (in a remote environment) Preferred: Project Management experience Experiences Cross Functional collaboration - Primary New Product Innovation - Secondary Accountability - Primary Influencing without Authority - Primary Managing Crisis Secondary Functional Breadth - Secondary Licenses and Certifications ISO 13485 Training Preferred ISO 14971 Training Preferred IEC 62366 Training Preferred IEC 62304 Training Preferred Language Skills Fluent English; excellent verbal and written communication skills 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 Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason. Show more Show less

You will be responsible for Mechanical design in the field of Medical Devices, with a focus on Medical Device Design Controls, Design Verification, and Validation processes. A minimum of 3 to 5 years of relevant experience is required for this role. As a Sustaining Engineer, you will lead Change Qualification projects for medical devices, collaborating with a diverse Cross-Functional Team. Your tasks will include developing test protocols, ensuring the quality of deliverables, and managing risk through proactive identification and mitigation planning. Proficiency in DesignControl process for Medical Devices is essential, along with expertise in Mechanical Engineering basics. You should possess strong project management skills and the ability to work independently. Additionally, you must have excellent oral and written communication skills, with a particular emphasis on technical writing. Knowledge of ISO13485 standards is advantageous for this position. Proficiency in software tools such as SolidWorks, 2D design, Tolerance Stackup, and MS Word/Excel/PowerPoint is required. However, eligibility for the role is not solely based on software tool proficiency but also on your overall expertise and experience in the field. To apply for this role, you must hold a B.E/B.Tech or higher degree in Mechanical Engineering. Your role will involve collaborating with stakeholders to drive technical solutions and effectively communicate complex engineering concepts. You should be self-motivated, detail-oriented, and capable of applying statistical methods to problem-solving. The position is based in Chennai, and the walk-in interview is scheduled for 26th July at HCLTech Elcot Sez, Chennai. Interested candidates can send their CV to laveena.deenadayalan@hcltech.com with the subject line "Application for Design Verification Engineer - Chennai".,

As a member of the Biocon Biologics team, you will be part of a company that is shaping the future of healthcare by prioritizing patients and aiming to impact a billion lives. Our focus on affordable innovation, patient centricity, and disruptive thinking drives us to deliver high quality biosimilars globally. We are a diverse, global company that values purpose and passion in our employees, who work together closely with partners and patients to bring innovative healthcare solutions to the market. Your role will involve leading the full lifecycle execution of medical device development programs, ensuring alignment with design control and regulatory standards. You will be responsible for managing program budgets, collaborating with internal and external stakeholders, overseeing project timelines, and identifying and mitigating risks. Additionally, you will facilitate partner interactions, review RFQs, maintain program dashboards, and champion continuous improvement in program governance and documentation. To excel in this role, you should have 8-10 years of experience in the medical device industry, with at least 5 years in project/program management, preferably in drug delivery systems. You should possess a strong understanding of design control, device development processes, and lifecycle management. Proficiency in tools like Microsoft Project, Excel, and PowerPoint is essential, along with experience working with global partners and cross-functional teams. Your behavioral and leadership skills will play a crucial role in your success, as you will need to effectively manage stakeholders, lead complex programs independently, and drive cross-functional alignment. A strategic mindset with attention to detail, risk assessment, and execution discipline will be key, along with a collaborative and adaptive approach to teamwork. Please note that this role is not suitable for IT professionals, as it does not involve core IT responsibilities.,

You will be responsible for mechanical design tasks related to industrial, construction, and Hydraulic Machinery. Your key duties will include designing mechanical structures for machinery, creating Bill of Materials for mechanical components, preparing manufacturing drawings & 3D modeling, designing fixturing and packing fixtures, coordinating with stakeholders for manufacturing, and demonstrating expertise in CAD tools. Proficiency in AutoCAD and CREO is mandatory. Additionally, you will be involved in benchmarking, competitor analysis, cost analysis, and value engineering to ensure high-quality design solutions. This role requires a Bachelor of Engineering (BE) degree and 3-8 years of relevant experience.,

As a Medical Mechanical Design Verification/Control Engineer at HCLTech in Chennai Shollinganallur, you will be joining a team that values innovation, growth, and impactful work. This is an opportunity to work on cutting-edge projects in SME and be a part of something transformative! The walk-in drive is scheduled for 21st July Saturday from 9AM to 2PM at HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, Chennai-600119. The position available is for Mechanical Design (Lead, Technical Lead /Sr Lead) with an experience requirement of 3-7 years. To be eligible for this role, you should have a B.E/B.Tech or higher education in Mechanical Engineering. Sustaining Engineers are expected to have experience in Medical Device Design Controls, Design Verification & Validation for 3 to 7 years. You should be adept with the Design Control process for Medical Devices and have led Change Qualification projects for medical devices, collaborating with multi-cultured CFT. Your responsibilities will include developing test protocols and test plans, ensuring the quality of deliverables, expertise in Mechanical Engineering basics, Risk Management, applying statistical methods to problem-solving, and driving solutions for technical issues. Additionally, you should be self-motivated, capable of working independently, possess strong project management skills, and have excellent oral and written communication skills including technical writing. Knowledge of ISO13485 would be an added advantage for this role. Proficiency in software tools such as SolidWorks, 2D Tolerance Stackup, MS Word/Excel/PowerPoint is required. Interested candidates can share their CV with Katherine Sylvia at Katherinesylvia.k@hcltech.com, including details such as Current Company, Current CTC, Expected CTC, Notice Period, and Location. Make sure to bring this call letter for the walk-in interview on 21st July.,

HCLTech WalkInDrive In Chennai for Mechanical Engineers on 26th July Saturday. CONSIDER THIS AS CALLLETTER Medical Mechanical DHF/ windchillPLM/Design Verification/Control Engineer- WalkIN on 26th July in Chennai Shollinganallur Join a team that values innovation, growth, and impactful work. Dont miss the chance to work with cutting-edge Project in SME and be a part of something transformative! Drive Date:26th July Saturday (9AM-2PM) Skill1: #DHF #remediation #DHFremediation Skill2: #Designcontrol #designverfication #designvalidation Skill3: #WindchillPLM in medical domain Contact Person: Katherine Sylvia Venue Location: #HCLTech Elcot Sez, 602/3, 138, Medavakkam High Road, Sholinganallur, #Chennai -600119 Position:Mechanicaldesign (Lead, Technical Lead) Experience: 2.5-9 years Job Location:Chennai Skill : Medical device, Design control, Design Verification, DHF, MDR, ISO13485, Risk management, DHF Remediation, WindchillPLM #changeorder #Designhistoryfiles #JD : B.E / B.Tech or higher education in Mechanical Engineering #EXPERIENCE : Sustaining Engineers should have Medical Device #DesignControls , #Design verification & Validation experience of 3 to 7 years. Adept with #DesignControlprocess for #MedicalDevices . Led Change Qualification projects for medical devices, working with multi-cultured CFT. Experience developing test protocols and test plans Ensures quality of deliverables, including design, data summary and interpretation and report generation. Expertise in #MechanicalEngineering basics. #RiskManagement (Proactive risk identification and mitigation planning) Self-motivated and capable of working independently & Strong project management skills. Knowledge on #ISO13485 would be an added advantage. Excellent Oral and written Communication (MUST prove Technical writing skills with samples and/or assessment during the interview) & Interpersonal skills #SOFTWARETOOLS : #Mechanical #SolidWorks , #2D #ToleranceStackup , MS Word/ Excel/ Power point, #Skill2#JD : #DHFRemediation Experience in gap assessment process such as Testing gap assessment, Standards gap assessment, Requirements gap assessment Knowledge in Design History File remediation #Skill3#JD : #windchillPLM #medicaldomain #BOMstructure #Changeorder Create, Revise, Release parts (ZFIN, ZRAW, ZSMI, ZMOD, ZNVL) in Wind-chill according to the requirements defined in WI Create, Revise, Release Documents (Protocols, Reports, FAB, TRAV, PFMEA, IFU, Drawing Specification, Device tracking kit etc) in Wind-chill according to the requirements defined in WI Update Document and Part structure Create, Update BOM structure Create Change order with change description and justification for change. Assign Change Activity Assignee and Peer Reviewer. Assign approvers to the Change Implementation Board for change orders per the approval requirements. Create manual Pre- and Post-Release Adhoc Tasks Follow up with approvers to get the COs reviewed and approved Release of the Change Orders in Wind chill #Contact Person: #KatherineSylvia Interested candidates can share their CV on below mail id Katherinesylvia.k@hcltech.com with Below details Current Company, Current CTC, Expected CTC, Notice Period, Location . CONSIDER THIS AS CALLLETTER

HCLTech WalkInDrive In Chennai for Mechanical Medical Design Verification Engineer on 26th July Saturday. ( Medical Devices experience - Preferable or equalent Experience) Job Location : Chennai DriveDate :26th July Saturday (9AM-2PM) Venue Location : Chennai HCLTech Elcot Sez, New Cafeteria 2nd Floor 602/3, 138, Medavakkam High Road, Sholinganallur,hashtag Chennai -600119 Position : Mechanicaldesign (Engineer, Lead) APPLY - https://lnkd.in/gHQ5PFt6 Experience : 2.5-9 years Skill : M edical device, Design control, Design Verification, DHF, MD, Design validation ISO 13485 DHF remediation D esign history files JD : B.E / B.Tech or higher education in Mechanical Engineering EXPERIENCE : • Sustaining Engineers should have Medical Device Design Controls, Design verification & Validation experience of 3 to 5 years. • Adept with Design Control process for Medical Devices . • Led Change Qualification projects for medical devices, working with multi-cultured CFT. • Experience developing test protocols and testplans • Ensures quality of deliverables, including design, data summary and interpretation and report generation. • Expertise in MechanicalEngineering basics. • RiskManagement (Proactive risk identification and mitigation planning) • Hands-on with Computing skills (Basics of Engineering calculations). • Ability to apply statistical methods to problem solving. • Drive solutions for technical issues and convince Stakeholders on technical issues, backed up with Engineering Basics & Judgment. • Self-motivated and capable of working independently & Strong project management skills. • Knowledge on ISO13485 would be an added advantage. • Excellent Oral and written Communication (MUST prove Technical writing skills with samples and/or assessment during the interview) & Interpersonal skills SOFTWARETOOLS : Mechanical SolidWorks , 2D ToleranceStackup , MS Word/ Excel/ Power point, (Note: Software tools are for guidance only; Knowledge and experience in a fore mentioned software tools alone is not an eligibility criteria / strategy to qualify a resource). ContactPerson : Katherine Interested candidates can share their CV on below mail id Katherinesylvia.k@hcltech.com Subject Line:Application for Design Verfication Engineer- Chennai https://lnkd.in/g-H4ztQM Role & responsibilities

Join our Sustaining Engineering Team and contribute to: New Product Development (NPD) Design History File (DHF) updates Risk Management & DFMEA Verification & Validation (V&V) Design Controls Required Candidate profile Experince range 4 to 15 years only. Medical experince is must. Only immediate and serving notice period required.

Desired Skills:Quality assurance, JIRA. DOORS, IBM SYNERGY, PTC INTEGRITYKnowledge of JAMA workflows or similar tools like JIRA. DOORS, IBM SYNERGY, PTC INTEGRITYUnderstanding of engineering lifecycle phases and design control processes is preferred. Required Candidate profile Proven ability to design and implement new processes and facilitate user adoption. Knowledge of Requirement Management and Test Management, Traceability. Experience validating third party tools

As a candidate for the position at Bengaluru Luxor North Tower, you will be expected to possess the following qualifications and skills: Agile and distributed decision-making using evidence and applying judgment to balance pace, rigor, and risk. You should be able to manage individual and team performance effectively, committed to delivering high-quality results, overcoming challenges, and focusing on execution. Implementing change initiatives, leading change, and sustaining energy and well-being in teams are essential aspects of the role. You should continuously seek opportunities to learn, build skills, and share learning both internally and externally. Developing people, building a talent pipeline, translating strategy into action, and building strong relationships and collaboration with stakeholders are key responsibilities. Budgeting, forecasting, commercial and financial acumen are necessary skills for this role. A bachelor's degree or above in engineering, manufacturing technology, pharmaceutical science, or a related field is required. Experience with 10-16 years in drug/device combination (DDC) product and/or medical device development, pharmaceutical development, biotechnology, manufacturing, and/or quality is necessary. Technical knowledge of product development processes, sterile drug product primary pack & devices, Design History File (DHF) assembly, maintenance, and/or remediation, project management, and organizational skills are crucial for success in this position. You should have knowledge and understanding of Good Manufacturing Practice (GMP), Pharmacopeia, and regulatory standards. Experience supporting regulatory audits, design control, risk management, and fluency in English (both written and oral) are important. Competence with the full MS Office Suite is also required. Preferred qualifications include experience in Manufacturing Science and Technology (MSAT) to ensure products are produced safely, efficiently, and to the highest quality standards. The successful candidate will align with GSK's values and expectations, including patient focus, transparency, respect, integrity, courage, accountability, development, and teamwork. GSK is a global biopharma company focused on uniting science, technology, and talent to positively impact the health of billions of people. Joining GSK means being part of an organization where people can thrive, innovate, and make a difference in preventing and treating diseases. If you share our ambition and values, this is an exciting opportunity to be part of our journey to get ahead together.,

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Job Summary Caterpillar is seeking a highly motivated and experienced Senior Design Engineer to join our team focused on genset applications. This role is critical in delivering high-performance, compliant, and manufacturable solutions. The ideal candidate will bring strong technical expertise in mechanical design and a collaborative mindset to work effectively with global teams Role Definition Designs, develops, builds, and implements new products, components, or technologies. Responsibilities Lead design and development of fuel tanks ensuring compliance with Caterpillars engineering standards and regional regulations. Perform structural integrity for seismic conditions, load distribution, lifting and transportation loads. Develop and validate sheet metal designs, ensuring manufacturability with knowledge of welding standards (heat load/warpage) and cost-effectiveness. Collaborate directly with global teams across the regions to align design requirements and project goals. Knowledge on Creo, PLMs and supplier engagement is added advantage. Required Qualifications Bachelors/Master's degree in Mechanical Engineering or a related field. Proven experience in fuel tank design, preferably for gensets or similar mechanical systems. Skill Descriptors Analytical Thinking Knowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems. Level Extensive Experience: Seeks discrepancies and inconsistencies in available information; explains variances. Organizes and prioritizes the sequence of steps to be taken to remedy the situation. Identifies many possible causes for a problem based on prior experience and current research. Quantifies the costs, benefits, risks and chances for success before recommending a course of action. Approaches a complex problem by breaking it down into its component parts. Chooses among a diverse set of analytical tools according to the nature of the situation. Effective Communications Understanding of effective communication concepts, tools and techniques; ability to effectively transmit, receive, and accurately interpret ideas, information, and needs through the application of appropriate communication behaviors. Level Extensive Experience: Reviews others' writing or presentations and provides feedback and coaching. Adapts documents and presentations for the intended audience. Demonstrates both empathy and assertiveness when communicating a need or defending a position. Communicates well downward, upward, and outward. Employs appropriate methods of persuasion when soliciting agreement. Maintains focus on the topic at hand. Managing Multiple Priorities Knowledge of effective self-management practices; ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation. Level Extensive Experience: Clarifies and handles multiple concurrent and diverse activities. Shifts focus among several efforts as required by changing priorities. Addresses potential conflicts that impact current delivery commitments. Works with or leads others to re-prioritize work and reschedule commitments as necessary. Responds to shifting priorities while maintaining progress of regularly scheduled work. Demonstrates an expectation that there will be ongoing shifts in demands and priorities. Technical Excellence Knowledge of a given technology and various application methods; ability to develop and provide solutions to significant technical challenges. Level Extensive Experience: Advises others on the assessment and provision of all technical solutions. Engages appropriate subject matter resources to effectively resolve technical issues. Mentors others to enhance their technical competence and its application to achieve more effective technical solutions. Coaches others in promoting, defining, analyzing, and providing superior technical solutions to business problems. Provides effective solutions to moderate technical challenges through strong technical competence, effectively examining implications of events and issues. Assumes accountability for personal technical performance and holds others responsible for theirs. Computer-Aided Design & Engineering Knowledge of tools and techniques of specialized graphics programs; ability to produce, analyze, simulate and test product design drafts. Level Extensive Experience: Coaches others on orthographic, isometric and axonometric projections. Presents complex products and systems graphically. Performs manipulations on design objects, such as changing projections and managing drawing layers. Directs the matrix computations performed to transform objects in coordinate space. Consults on benefits and drawbacks of top-down design vs. bottom-up design. Compares and contrasts uses of bird's-eye views and worm's-eye views. Product Design - MFG Knowledge of processes, approaches, tools and techniques of product design; ability to convert customer and market requirements into product design. Level Extensive Experience: Develops improvement plans for senior management and evaluates the outcome of the design against the functionality. Advises others on the development of multiple products and their functionality. Trains others on advanced tools and approaches of product design. Monitors the processes and procedures of a complex product design to ensure functional requirements are met. Evaluates feedback from customers and consults on functional weaknesses. Controls design and development costs of a proposed product through effective resource coordination. Product Design and Developmen tKnowledge of product features; ability to design, build, and develop a new product, technology, or service from concept through to production. Level Extensive Experience: Develops organizational standards and processes in order to maximize complex product services' efficiency and effectiveness. Creates and introduces new techniques that expedite or simplify the development process. Supervises the management of multiple and diverse types of products or services. Develops proof-of-concept exercises to prove or disprove validity of proposed products. Advises on the appropriate solutions to complex product design and development problems. Designs working prototypes of a variety of proposed products or services. This is intended as a general guide to the job duties for this position and is intended for the purpose of establishing the specific salary grade. It is not designed to contain or be interpreted as an exhaustive summary of all responsibilities, duties and effort required of employees assigned to this job. At the discretion of management, this description may be changed at any time to address the evolving needs of the organization. Posting Dates: July 2, 2025 - July 17, 2025 Caterpillar is an Equal Opportunity Employer. Not ready to applyJoin our Talent Community.

Responsibilities: * Collaborate with design team on project requirements and specifications. * Maintain cleanliness and organization of workspace. * Load, operate, and unload 3D printers safely.

Role & responsibilities Leads the evaluation and development of Disposables on assigned projects with focus on risk management. Owns and maintains the risk management files for the assigned product families. Manages all technical complexities of the work, and effectively communicates with all project team members and stakeholders. This includes reporting pertinent information at key milestones. Collaborates with cross functional team (e.g., Quality, regulatory, clinical) to ensure the proper deployment of risk management activities. Manages and prioritizes multiple projects and tasks. Develops solutions and approaches to complex problems through application and adaptation of state-of-the-art techniques. Able to clearly present moderately complex concepts and tailor communication to audiences, including senior management. Organizes and presents solutions from risk management perspective without assistance. Oral and written communication is well planned, organized and has a clear logical flow. Ensures successful integration of disposables design elements from risk management perspective into the overall system. Resolves competing constraints between interrelated functions (R&D, purchasing, manufacturing, regulatory, marketing, etc.) required to complete the risk management tasks. Creates and maintains design documentation that includes requirements, specifications, verification reports, Bill of Materials, detailed engineering drawings, study reports and all documents that contribute to DHF of the product family. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing ensuring acceptable risk profile of the device is maintained throughout the entire product lifecycle. Support, from risk management perspective, the necessary testing required to validate the safety and effectiveness of the design(s). Preferred candidate profile Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent Minimum of 6 years of relevant experience, Prior experience of technical leadership in Sustenance/New product development in Critical care Medical device domain is a plus. Experience in a regulated industry preferably medical devices and familiarity with ISO 13485, and ISO 14971 Qualifications Proficiency with MS Office and other office productivity tools. Self-directed, resourceful, and able to work on multiple projects and priorities. Strong organization, attention to detail, and documentation skills. Strong hands-on lab skills, and prototype fabrication skills. Very adept at grasping and solving complex problems using root-cause analysis techniques. Previous experience on product risk management is a plus. Ability to objectively identify technical solutions, and make sound engineering decisions. Clear and effective communication (written and oral) and presentation skills. A proven track record of effectiveness in a fast-paced environment. Proven ability to create results within budget, timeline, and product/project deliverables.

Join our Sustaining Project Team as a Design Quality Engineer. Handle DHF, risk management, V&V, doc control, and ensure compliance with quality systems & regulatory standards. Experience with PLCP, FMEA, and CAPA is preferred. Required Candidate profile This role is strictly focused on Design Quality Engineering. It does not include Regulatory Affairs or Post-Market Surveillance (PMS) responsibilities.

Career Area: Engineering : Your Work Shapes the World at Caterpillar Inc. When you join Caterpillar, you'rejoining a global team who cares not just about the work we do but also about each other. We are the makers, problem solvers, and future world builders who are creating stronger, more sustainable communities. We don'tjust talk about progress and innovation here we make it happen, with our customers, where we work and live. Together, we are building a better world, so we can all enjoy living in it. Role Definition Engineering support for Large Power Systems Products (Reciprocating Engines & Gensets) Manufacturing towards effective Built in Quality and issue resolution Responsibilities Design support for operations team during introduction and regular production of engines and gensets, support resolve issues from shop floor with high velocity Built in Quality engineering issue resolution and communication, document and review all issues with appropriate issue owners, working with cross functional team to implement design fixes/changes, Work with design control and platform team to resolve / approve any required deviations and PCNs working closely with other engine / genset design team members and other component teams, as well as validation engineers to determine component and pack configuration, design, detailing and problem resolution Participate in the design processes in a manner to ensure products provide superior performance, durability, quality, and serviceability Assisting supply specialists and buyers with supplier development and supplier performance. Overseeing the efforts of drafting and testing specialists. Understanding and adhering to project schedule Support CQMS, ISO 9001 and ISO 14001 documentation and audits, support and work in non-normal business hours as needed to work with global team Requires a degree in an accredited Mechanical / Electrical Engineering degree or equivalent, experience working in Power Systems (Reciprocating Engines / Genset) Product Development / Factory Support Requires Proficiency with ProE, TeamCenter, and other design / BOM management tools, knowledge of New Product Introduction and Current product issue resolution processes Requires Proficient communication skills Degree RequirementDegree requiredSkill DescriptorsData Gathering & AnalysisKnowledge of data gathering and analysis tools, techniques, and processes; ability to collect and synthesize data from a variety of stakeholders and sources in an objective manner to reach a conclusion, goal, or judgment.Level Basic UnderstandingDescribes alternative data-gathering techniques and tools. Documents basic data-gathering methodologies. Identifies the purposes of data gathering and analysis. Identifies key objectives in gathering and analyzing data.Analytical ThinkingKnowledge of techniques and tools that promote effective analysis; ability to determine the root cause of organizational problems and create alternative solutions that resolve these problems.Level Basic UnderstandingNames specific tools or techniques that can be used to support the analytical thinking process. Describes specific software applications or products used for business analytics. Gives examples of how analytical thinking has been used to resolve problems. Helps others research and learn more about business analytics tools and applications.Decision Making and Critical ThinkingKnowledge of the decision-making process and associated tools and techniques; ability to accurately analyze situations and reach productive decisions based on informed judgment.Level Basic UnderstandingExplains characteristics and steps in an effective decision-making process. Identifies issues and communicates with others when a decision needs to be made. Names decision makers in own environment and cites examples of past decisions. Describes types of decisions incumbent may and may not make in own job or function.Effective CommunicationsUnderstanding of effective communication concepts, tools and techniques; ability to effectively transmit, receive, and accurately interpret ideas, information, and needs through the application of appropriate communication behaviors.Level Working KnowledgeDelivers helpful feedback that focuses on behaviors without offending the recipient. Listens to feedback without defensiveness and uses it for own communication effectiveness. Makes oral presentations and writes reports needed for own work. Avoids technical jargon when inappropriate. Looks for and considers non-verbal cues from individuals and groups.Technical ExcellenceKnowledge of a given technology and various application methods; ability to develop and provide solutions to significant technical challenges.Level Basic UnderstandingUses a structured approach in analyzing and resolving technical problems. Seeks opportunities for continual learning to maintain technical competence in pursuit of technical excellence. Provides examples or case studies demonstrating technical excellence in actual business scenarios. Pursues, prepares for and assumes new technical assignments and challenges.3D SoftwareKnowledge of the types, features and tools of 3D software; ability to use, implement, test and upgrade the software package in the process of 3D models production.Level Working KnowledgeAssists in designing 3D models using appropriate software. Helps others to install and maintain 3D modeling and rendering software. Discusses the pros and cons of competitive 3D software from a business perspective. Works with the standard features and facilities of 3D software. Asks industry experts about the usage and functionality of a particular 3D rendering software.Product TestingKnowledge of product testing approaches, techniques and tools; ability to design, plan and execute testing strategies and tactics to ensure product quality at all stages of manufacturing.Level Basic UnderstandingDescribes key features and aspects of a specific testing discipline or methodology. Describes common errors that are uncovered by product testing. Cites examples of testing tools and practices currently in use. Names key documentation (paper, audio, video) required during the testing process.Troubleshooting Technical ProblemsKnowledge of troubleshooting approaches, tools and techniques; ability to anticipate, detect and resolve technical problems in a manufacturing or product development environment.Level Basic UnderstandingExplains where to locate basic help facilities and troubleshooting guides. Discusses basic concepts behind a systematic approach to solving technical problems. Identifies available resources and support systems for troubleshooting. Describes problem identification, reporting and escalation procedures.This is intended as a general guide to the job duties for this position and is intended for the purpose of establishing the specific salary grade. It is not designed to contain or be interpreted as an exhaustive summary of all responsibilities, duties and effort required of employees assigned to this job. At the discretion of management, this description may be changed at any time to address the evolving needs of the organization. It is expressly not intended to be a comprehensive list of essential job functions as that term is defined by the Americans with Disabilities Act."

Mechanical design : Experience in industrial, construction andHydraulic Machinery willbe preferable. 1. Design of mechanical structures for machinery, 2. Creation of Bill of materials for mechanical components, 3. Preparation of manufacturing drawings & 3D modelling, 4. Fixturing and packing fixtures design expertise, 5. Coordination with stakeholders for manufacturing, 6. Very good hands-on experience in CAD tools. Expertise in AutoCAD and CREO mandatory, 7. Benchmarking, competitior analysis, cost analysis and value engineering Mechanical design : Experience in industrial, construction andHydraulic Machinery willbe preferable. 1. Design of mechanical structures for machinery, 2. Creation of Bill of materials for mechanical components, 3. Preparation of manufacturing drawings & 3D modelling,

Key Deliverables: Provide quality oversight across design, validation, and lifecycle of combination products Support regulatory submissions, audits, and RTQ responses Ensure compliance with global standards including ISO 13485 and 21 CFR Lead quality process improvements for device, labeling, and packaging Role Responsibilities: Act as single point of quality contact for final product activities Review risk management, HFE documentation, and design controls Train teams on quality and regulatory requirements for combination products Manage complaint investigations and site transfer quality activities

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.. You will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing Disposable subsystems of dialysis product portfolio. The successful candidate will possess solid “hands-on” technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.. Leads the evaluation and development of mechanical and Fluid control systems by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.. Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled. Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies. Ensures successful integration of mechanical design entities with interface Systems and consumable components.. Contributes to troubleshooting and problem solving efforts related to mechanical and regulatory aspects of the design and interfaces with other design constituents.. Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards within area of responsibility/expertise. Defines the required tasks, test plans, deliverables, and technical direction. Constructs detailed, accurate project schedules interfacing with product development, quality, regulatory, manufacturing, and other cross functional teams.. Contributes to development and documentation of mechanical systems architectures.. Able to design Plastic components with expertise in manufacturing of plastic components. Able to effectively transition products to manufacturing and ensure robust products and manufacturing processes. Improves mechanical designs that are optimized for production, reliability, regulatory compliance and cost.. Leads troubleshooting and problem-solving efforts of the products associated with field performance and manufacturing. Ensures Systems that are optimized for production, reliability, regulatory compliance, and cost.. Performs in-depth mechanical engineering analysis/FEA/CFD and calculations.. Responsible for integration of deliverables from sub-system design teams and external partners.. Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.. Defines protocols and conduct the necessary testing required to validate the safety and effectiveness of the design(s).. Qualifications. A graduate or a post graduate in Mechanical or related engineering and 14+ years related experience. Prior experience in Renal device/Medical domain is a plus.. A demonstrated track record in Plastic component design and development, preferably medical devices or other highly regulated product domain such as aircraft/automotive/defense industries.. A proven track record of effectiveness in a fast paced environment.. Proven ability to create results within budget, timeline, and product/project deliverables.. Reasonable Accommodation. Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link. Recruitment Fraud Notice. Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.. Show more Show less

Role & responsibilities: Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Responsible for monitoring and management of projects in assigned division / sub-division / ULBs. Day-to-day supervision of construction works including design control, quality assurance and quality control, schedule, and budget control. Assessing adequacy of contractors plant, equipment, materials, labour to carry out works as the per approved work program. Performance monitoring of works contractors. Report on tests. Review of contractors submittals such as work plans, work schedules, method statements, progress reports, designs, and drawings, etc. Preparation of daily, weekly, monthly progress reports. Maintaining photographic records of each assigned project. Minimum Qualification & Work Experience Required: Bachelor’s in Civil Engineering is required. Atleast 12 years’ of overall experience with 5 years’ of relevant construction supervision experience of water supply and used water infrastructure projects.

What this job involves You will be responsible to ensure all necessary utilities are being given to the occupants/tenants. You will be responsible for all drawing submissions and approvals to be maintained for fitout work. The contractor will coordinate with you for all minor execution issues. Building maintenance and upkeep will be one of your KRA. Your key deliverables will be: Maintain records of all building drawing. Make sure all instruction guidelines are being followed as per the fitout manual. Provide necessary permits (Night work, hot work, height work). Coordinate for all necessary security arrangements for execution of fitout activities. Monitor and control work in progress as per approved plan by the client. Ensure completion of Snagging and De-snagging work of flats Common area. Ensure all safety requirements are being followed at the site. Advise contractor on minor execution issues. Ensure that all work meets client design control specifications. Daily visit to ongoing fit-out work for checking of civil work layout. Working closely with management to help improve and maintain the building in clean and maintenance free condition. You will be meeting with all clients who are going to start the fit-out work to resolve queries of clients regarding the working procedures, instruction and for material handling as per approved drawings and other documents related to fit out work and operation activities. Maintain a fitout tracker. Providing the clients with suitable energy conservation plans. Coordinate and maintain the as-built drawing and transition document library. Work closely with the regional RO HO SME/ Training teams and ensure closures of all required reports. Facilitate the services under the Slogan No Safety No Work. Site dynamics: 1. Work Schedule: 2. Site team: e.g.: Property Manager +2 3. Other details if any. Reporting: You will be working with our operations team and reporting to the Property Manager. Sound like you Here is what were looking for: Being Analytical and Meticulous Your role will involve coordination with various teams/ vendors. You will be paying attention to detail and have excellent problem-solving skills. You will be using logic to trouble-shoot problems; and assign and monitor maintenance projects. You should have a good knowledge of the working procedures for fitout. Qualifications You will have a Degree Diploma or relevant educational background in Civil Engineering with minimum 1-2 years of work experience. On-site Mumbai, MH

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.

Your key responsibilities The Senior will support teams of FAAS professionals during engagements covering a broad spectrum of Process and Control areas. The Senior will be responsible for the following tasks: Responsible for executing client related engagements in the areas of governance, risk & compliance (GRC), process reviews, standard operating procedures, enterprise risk management, SOX, Internal Control over Financial Reporting (ICFR). Supporting SOX engagement, Process and Control; or should be an expert in driving Financial Statement Close Process, Procure to Pay and Order to Cash, Inventory, Fixed Assets, PPE & Intangible assets processes (along with experience in Risk management) Supporting projects related to Process Improvement and Implementation, drafting risk and control matrix, process placemats and documenting SOPs. Supporting engagement planning, budgeting, execution and management Preparing products/deliverables meet contract/ work plan specifications and deadlines Supporting the development of tools and methodologies for project delivery Participating in meetings and interviews with client personnel Developing creative, yet practical, solutions to help our clients achieve their Process and Control objectives Developing client deliverables and engagement documentation Developing, tracking and supporting actual engagement economics versus the budget Supporting the development and management of the relationships with external and internal clients Supporting development of new service offerings and go-to-market strategies Supporting other ad-hoc internal initiatives geared towards improving our groups efficiency, effectiveness and integration with other service lines To qualify for the role, you must have Chartered Accountant (CA), CPA (US) or ACCA (UK) with 3+ years of experience with a large Global Corporate Process, Risk and Control department and/or similar experience MBA degree is a plus Experience with the following Process and Control areas: Governance, controls and regulation Governance, Risk & Compliance Process and Control Process reviews Standard Operating Procedures Enterprise Risk Management Revenue Assurance SOX Internal Control over Financial Reporting (ICFR) Design and Implementation testing

Job Description Job title: Quality Engineer, Products and Systems Your role: Be part of Project team and participate in defining product design input, requirements, V&V, output and design transfer requirements and plans. Ensure product quality, compliance and state of art throughout the product lifecycle. Reaffirm that design input are transferred to product design and verified to confirm that design output meet the design input. In collaboration with multi-disciplinary team, lead the design for reliability to create a reliability plan and include the reliability requirements in product design. Ensure that reliability requirements are met through test, verification and validations, as applicable. A distinguished champion on patient safety and quality with expertise on quality and compliance principles like IEC60601, IEC 62304, IEC62366, 21CFR806. You will be acting as subject matter expert to provide guidance on product design quality, safety, reliability, serviceability, maintainability, manufacturability and other aspect in collaboration with business and technical SMEs. Well conversant with QMS requirements in accordance with ISO13485:2016 and ISO14971. Expert in medical device risk management principles including risk evaluation, assessment, risk determination, mitigation and risk benefit analysis. You will be acting as facilitator for risk management activities in accordance with ISO14971 and other applicable regulatory requirements. You're the right fit if: (4 x bullets max) Experience: 12 to 20 Years, minimum 10 years in Medical device industry. Bachelor's in engineering or quality management, with 12 to 20 Years, minimum 10 years in Medical device industry. Proven knowledge of the FDA regulations for Design Controls for medical devices is a must and the combination with (extensive) experience with regulatory inspections has a very strong preference. Product Quality Engineering and Design Control experience is a requirement. Certification in Software Quality Engineering (CSQE) from ASQ or other bodies is desirable In-depth knowledge and a proven track record in implementing and applying concepts in the fields of designing in quality, reliability and problem-solving techniques have a strong preference. Leadership experience and good change management and influencing skills (required) You are Customer, Patient Safety and Quality focused. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR. Advanced level knowledge of IEC62304, IEC62366 and ISO14971 has a strong preference. Excellent communication skills, able to clearly and concisely summarize complex technical problems You combine analytical and conceptual thinking, physical insight, system view, flexibility and a Handson mentality to deliver sustainable results and creative solutions. You are a motivated self-propelling person, with determination to succeed and the ability to manage change. Excellent organizational skills to lead and track deliverables Strong influencing skills power of persuasion, perseverance, getting things done mentality. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companyu2019s facilities. Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. u2022 Learn more about . u2022 Discover . u2022 Learn more about . If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere For 70 years, our team has driven meaningful innovations in kidney care As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients? that is what Vantive aspires to deliver, We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us is driven to help improve patientslives worldwide Join us in advancing our mission to extend lives and expand possibilities, Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us, At Vantive, you will become part of a community of people who are focused, courageous and dont settle for the mediocre Each of us are driven to help improve patientslives worldwide Join us as we revolutionize kidney care and other vital organ support, Summary The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems, Vantive is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities, The Kidney Care R&D Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology) As a member of the Drug Products and Sciences organization, the Lead System Integrator co-ordinates/leads DPS R&D activities within a Project or Program with her/his Project Management and Technical Leadership skills This role may be responsible for supporting multiple projects, Essential Duties and Responsibilities This section contains a list of five to eight primary responsibilities of the work The incumbent will perform other duties as assigned, Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products Owner of R&D program schedule creation, tracking, and execution Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans, Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables Accountable for project execution and proactive risk management Effectively tracks project status, risks, budget, and external spend, Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project Establish project communication channels and archives e-g , Teams group, Status meetings, Escalation matrix, etc Facilitate/organize DPS R&D project design reviews and change control meetings Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e-g , external labs, translation agencies, etc ) Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily List knowledge, skills, and/or abilities required, Experience in project management principles and methodologies Strong interpersonal and communication skills in written and verbal form Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc ), Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope, Ability to decompose complex problems into actionable plans and track them to closure Understanding of design requirements for development, validation, and verification of medical products Education and/or Experience Include the education and/or experience that is necessary to perform the job satisfactorily, Bachelors degree in Engineering, Science or related field 10+ years of relevant R&D, Project management (or similar) experience preferred Experience in pharmaceuticals or medical product industry preferred Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information To learn how you can protect yourself, review our Recruitment Fraud Notice,