Design Quality Engineer II

Careers that Change Lives

· Responsible for providing quality engineering support in design, development, and sustaining activities for low complexity and complex medical device products.

A Day in the Life

· Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.
Must Haves

· 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.

Minimum Qualification

· B E or B.Tech

· Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience
Key Technical Competencies

· 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 +001, ISO 13485, IEC 62304, ISO 14+71, 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
Nice to Haves

• Medical Devices experience

• ASQ CQE, CQA, CSQE and/or CRE certification.

• DFSS / Lean Green Belt or Black Belt
About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives.Help us shape the

future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.