Medical Device Design Controls & Remediation Engineer

About the role

We are looking for dynamic consultants to grow our Life Sciences team in Bothell, Washington. Your experience, knowledge, and commitment will help us to face our client’s challenges. You will be supporting different projects through your expertise as Medical Device Design Controls & Remediation Engineer.

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.

Why choose us

• An international community bringing together more than 110 different nationalities.
• An environment where trust is central: 70% of our leaders started their careers at the entry level.
• A strong training system with our internal Academy and more than 250 modules available.
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.).