Design Quality Engineer II

Responsibilities may include the following and other duties may be assigned

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.
• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting, , and feasible product requirements that support the market needs
• Complaint Handling Experience for the medical devices products
• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
• Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
• Strong in software design and development, software verification and validation activities
• Oversee testing and analysis for standards and product requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
• Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
• Review Design History Files and Technical Files for conformance to applicable requirements
• Ensures applicability to SOUP / OTS validations in the product development
• Participate when appropriate in audits
• Participate and provide input to training on department / division procedures and policies
• Participate when appropriate in internal and supplier audits.
• Applies quality system regulations, applicable standards and guidance to multiple projects
• Applies quality system regulations, applicable standards and guidance to multiple projects
• Develops templates and training based on the quality system regulations, applicable standards and guidance.
• Independently reviews all SW deliverables to ensure compliance with development process and the standard.
• Delivers presentations to the QA organization on status and issues of assigned projects. Delivers training to departments outside of QA.

Required Knowledge and Experience

• B E or B. Tech
• Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience
• 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 including protocol / report development and technical presentations.
• Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Root cause failure analysis.
• Previous experience working in a cross-functional team environment.
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistical)
• Familiar with DMAIC or DMADV(DFSS) methodologies

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.

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 R&D 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