Job Description

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



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