✦ Luna Orbit — Healthcare & Medical

Senior Medical Device Design Quality Engineer

at Analog Devices

📍 US, MA, Wilmington Unknown 💰 $110K – $151K USD / year Posted March 13, 2026
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Position Details

Salary $110K – $151K USD / year
Type Not Specified
Experience senior
Exp. Years Not specified
Education Bachelor's degree in engineering or scientific discipline
Category Healthcare & Medical

About this role

This role involves ensuring the quality, safety, and regulatory compliance of medical devices through design review, risk management, and quality system support.

Key Responsibilities

  • Provide design quality support
  • Review engineering designs
  • Facilitate risk management activities
  • Ensure compliance with QMS
  • Support CAPA activities

Technical Overview

The position requires expertise in medical device design quality, risk analysis, cybersecurity considerations, and compliance with FDA and ISO standards.

Ideal Candidate

The ideal candidate is an experienced senior medical device design quality engineer with a strong background in risk management, regulatory compliance, and quality systems within the medical device industry. They possess deep technical expertise and excellent collaboration skills to ensure product safety and compliance throughout development and post-market activities.

Must-Have Skills

Medical device design qualityRisk managementRegulatory complianceQuality Management System (QMS)Root cause analysisCAPA activities

Nice-to-Have Skills

Cybersecurity requirementsDesign validationDesign reviewProduct development lifecycle

Tools & Platforms

ISO 13485FDA regulationsDesign control tools

Required Skills

Medical Device DesignRisk ManagementDesign Failure Modes and Effects AnalysesCybersecurityRegulatory complianceQMSCAPARoot Cause AnalysisFDA regulationsISO 13485

Hard Skills

Design Quality EngineeringMedical Device DesignRisk ManagementDesign Failure Modes and Effects AnalysesCybersecurity requirementsRegulatory complianceQuality Management System (QMS)Standard Operating Procedures (SOP)Root Cause AnalysisCorrective and Preventive Actions (CAPA)

Soft Skills

Technical problem-solvingCross-functional collaborationPartneringCommunicationTeamworkContinuous improvement

Industry & Role

Industry Healthcare & Medical
Job Function Medical device design quality assurance and regulatory compliance

Keywords for Your Resume

Design Quality EngineeringMedical Device DesignRisk ManagementDesign Failure Modes and Effects AnalysesCybersecurityRegulatory complianceQuality Management SystemStandard Operating ProceduresCAPARoot Cause AnalysisFDA regulationsISO 13485Design controlPost-market surveillanceHazard AnalysesQMSFDA

Deal Breakers

Lack of experience in medical device quality engineering, No knowledge of FDA or ISO 13485 standards, Bachelor's degree in unrelated field, No experience with risk management or CAPA, Unwillingness to work in Wilmington, MA

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