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Provide design quality engineering support in design and development of medical device products. Facilitate the application of design controls in product development and sustaining changes.

A Day in the Life

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

· Capable of mentoring junior quality engineers in providing quality engineering support for their medical device products.

Must Have

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

· Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, IEC 62304, ISO 14971, IEC 60601 and other relevant industry standards during product development and changes.

· Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, Hazard Analysis, DFMEA, and risk management report).

· Should have hands on experience in software verification

· Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.

· 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.

· Strong in software risk management, software design and development, software verification and validation activities

· Review Design History Files and Technical Files for conformance to applicable requirements.

· Provides guidance to associate and level 1 quality engineers.

· Participate and provide input to training on department / division procedures and policies

· Acts as the subject matter expert on risk management for one or more products/platforms.

· Ensures applicability to SOUP / OTS validations in the product development

· Deliver presentations to the QA organization on status and issues of assigned projects.

Deliver training to departments outside of QA.

· Provide Quality support to facilitate resolution of product complaints and/or safety issues

· Hands-on experience on complaints analyis, Post market surveillance, Design Controls for Medical Devices.

Minimum Qualification

· B E or B.Tech

· Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience

Key Technical Competencies

· Previous experience working in a cross-functional team environment.

· Familiar with statistical software tools (Minitab, Stat Graphics)

· 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.

· 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 andtechnical presentations.

· Strong in software design and development, software verification and validation activities

· Computer literate and experience with PCs, networks, applications, software development life cycle

· Knowledge in cybersecurity

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

· Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.

· Familiar with DMAIC or DMADV(DFSS) methodologies

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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.