Careers that Change Lives

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.

· Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.

· 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.

· 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 design and development, software verification and validation activities

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

· Participate when appropriate in audits

· Demonstrates mastery of software development and testing methodologies

· Independently develops test strategies for new, pre-concept features in development.

· Provides guidance to associate and level 1 quality engineers.

· Assesses the compliance of the software development methodology to the approved process.

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

· Facilitates hazard analysis and SFMEA sessions. Updates the risk management file.

· 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

· Participates on CCB to decide upon CR implementation.

· Applies quality system regulations, applicable standards and guidance to multiple projects

· Develop 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.

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

Deliver training to departments outside of QA.

· Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.

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

· Hands-on experience on Risk Management, Design Controls.

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

· Provide support to the Regulatory Department in writing technical submissions.

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

· Travel may be required

· 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

Your Answer

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About Medtronic

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