Position Details

Salary $79K – $127K USD / year

Type Full-Time

Experience senior

Exp. Years 5+ years

Education Bachelor's degree in biomedical/mechanical engineering (BS) with 5+ years or Master's with 3+ years

Category Healthcare & Medical

About this role

Senior quality engineer responsible for leading design assurance activities for Shockwave Reducer projects, ensuring compliance with medical device quality systems and regulatory requirements.

Key Responsibilities

Lead quality assurance for new product development
Ensure DHFs are complete and inspection-ready
Develop and maintain Risk Management Files
Support V&V, process validation, and design transfer
Participate in regulatory audits and submissions

Technical Overview

Focus on design controls, DHFs, V&V, TMV, risk management (ISO 14971), regulatory submissions (510(k), CE, PMA) and audits; experience with Windchill and MES for design transfer and manufacturing readiness.

Ideal Candidate

A senior quality engineer with 5+ years in medical device design assurance, proficient in V&V, TMV, risk management, and regulatory submissions. Experience with ISO 13485, ISO 14971, FDA QMSR, and audits is essential.

Must-Have Skills

Degree in biomedical/mechanical engineering5+ years medical device industry experience (BS)V&VTMVand risk management experienceISO 13485ISO 1497121 CFR 820 / FDA QMSREU MDR

Nice-to-Have Skills

Experience with Class II/III devicesExperience with biocompatibility and sterilizationPLM/MES experienceKnowledge of IEC 62366-1 usability

Tools & Platforms

WindchillManufacturing Execution SystemsPLM

Required Skills

Design Verification and ValidationTest Method ValidationRisk ManagementFMEAISO 13485ISO 1497121 CFR 820 / FDA QMSREU MDRDesign History FilesDHFsV&VTMV

Hard Skills

Design Verification and Validation (V&V)Test Method Validation (TMV)Risk ManagementFMEAFDA GMPISO 13485ISO 1497121 CFR 820 / FDA QMSREU MDR (2017/745)Design History Files (DHFs)DHFsStatistical methodsMinitabV&V activitiesDesign transferIQ/OQ/PQRegulatory audits510(k)CE Technical FilesPMA modulesWindchillPLMMES

Soft Skills

Cross-functional collaborationCommunicationProblem solvingAttention to detailSelf-direction

Certifications

Preferred

LeanSix Sigma or Design for Six Sigma

Industry & Role

Industry Healthcare & Medical

Job Function Lead design assurance activities for new medical device products from development through transfer to manufacturing.

Role Subtype Senior Quality Engineer

Tech Domains Windchill, Manufacturing Execution Systems

Keywords for Your Resume

senior quality engineerdesign assuranceshockwavereducerISO 13485ISO 1497121 CFR 820FDA QMSREU MDRDesign History FileDHFsRisk ManagementFMEAGMPV&VTMVstatistical methodsMinitabWindchillPLMMESregulatory audits510(k)v&vtmvfmeaiso 13485iso 14971fda qmsreu mdrwindchill

Deal Breakers

Bachelor's degree in biomedical/mechanical engineering, 5+ years medical device experience, Experience in ISO 13485 and regulatory audits, Willingness to travel as needed

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Sr. Quality Engineer, Design Assurance - Shockwave (Reducer)

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