Job descriptionYou will be supporting different projects through your expertise as
Medical Device Design Controls & Remediation Engineer.Your main responsibilities:
- Identify and remediate gaps between user needs, design requirements, risk analyses, and verification/validation evidence across multiple medical device product families.
- Author and update design control documentation, including requirements specifications, DFMEA, PFMEA, UFMEA, Risk Management Matrices (RMM), and V&V protocols and reports.
- Build and repair end-to-end requirements traceability from business, user, and regulatory requirements through verification evidence and product documentation.
- Develop verification and validation test protocols where evidence is missing, ensuring compliance with FDA and ISO design control requirements.
- Prepare and structure remediated documentation for migration from legacy systems (e.g., Windchill) into CodeBeamer or other ALM platforms.
- Track remediation activities, documentation gaps, deliverables, and program metrics using Azure DevOps and communicate progress to program stakeholders.
Qualifications:
- Bachelor's or Master's degree in Biomedical, Systems, Mechanical, Electrical Engineering , or a related engineering discipline.
- 3-7+ years of experience in medical device product development within a regulated design controls environment.
- Strong hands-on experience with ISO 14971 risk management , including DFMEA, PFMEA, UFMEA, and Risk Management Matrix (RMM) activities.
- Proven experience authoring verification and validation protocols, reports, requirements specifications, and traceability documentation .
- Working knowledge of FDA Design Controls / 21 CFR 820.30, ISO 13485 , and ALM/requirements management tools such as CodeBeamer, Polarion, IBM DOORS, or Windchill .
- Excellent technical writing, analytical, organizational, and communication skills, with professional fluency in English and the ability to work effectively in a cross-functional hybrid environment.
