About the position
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. In this exciting role as a Senior Product Test Engineer, you will be responsible for product verification and reliability test planning, designing, developing, and implementing testing methods and equipment for new product development and sustaining projects relating to infusion pump systems. This role is a part of the product Design Verification & Reliability Engineering group, which is in the Mechanical Engineering department of the Diabetes Operating Unit. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements, which include hardware product verification & reliability test related work to ensure compliance. Define test configurations and lab needs for sample testing and specifies tests to be performed. Compile data and defines changes required in testing equipment, testing procedures, manufacturing processes, or new testing requirements. Responsible for writing verification test plans and reports. This individual will ensure that all program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure product reliability and verification driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.
Responsibilities
- Plan and execute large, complex verification and reliability test strategies for medical device product development programs.
- Collaborate with systems engineering and product development teams to develop and evaluate designs.
- Develop, coordinate and conduct technical product design verification and reliability demonstration.
- Lead the development, modification and design review of plans, reports, protocols, data summaries & record.
- Use statistical techniques or data analysis to inform design decision making and conclusions.
- Partner and review risk management deliverables like DFMEA/PFMEA and Hazard Analysis.
- Utilize risk management and robust design principles to develop test methodologies.
- Assist supplier quality engineering and purchasing teams in vendor development and component engineering qualification activities.
- Participate on project teams and technical review boards and lead change control evaluations.
- Coordinate quality decisions between different quality and engineering groups.
- Lead CAPA projects and assist post market analysis.
- Participate in support of external and internal regulatory audits and inspections.
Requirements
- Requires a Bachelor's degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
- Experience working in a regulated industry (e.g., FDA-regulated).
- Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
- Master’s Degree in Engineering, Quality, Regulatory, or related.
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, IEC 60601-2-24 and MDD.
- Understanding of the interdependencies of program work products.
- Experience with planning and executing design verification testing, test method development and test method validation.
- Experienced with statistical analysis of data (e.g., MATLAB, Minitab, Weibull ++, etc.).
- Experienced with data acquisition software (e.g., NI LabVIEW, etc.).
- Experienced with fixture design and 3D modeling software (e.g., SolidWorks).
- Experience with DFMEA, Accelerated Life Testing, Risk Analysis, Reliability Growth, and/or Demonstration Testing.
- Working knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions.
- Ability to author technical reports, business correspondence and standard operating procedures.
- Strong verbal and written English communication skills.
Nice-to-haves
- Ability to multi-task, prioritize, meet/exceed deadlines and hold themselves, and others accountable.
- Self-Starter with a sharp focus on quality and customer experience.
Benefits
- Health, Dental and vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance/reimbursement.
- Incentive plans.
- 401(k) plan plus employer contribution and match.
- Short-term disability.
- Paid time off.
- Paid holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
