Medical Device Design Controls & Remediation Engineer (MedTech)

TL;DR

Medical Device Design Controls & Remediation Engineer (MedTech): Remediating gaps between user needs, design requirements, and V&V evidence for medical device product families with an accent on risk management and design control documentation. Focus on building end-to-end traceability, developing V&V protocols, and migrating documentation to ALM platforms.

Location: Hybrid (Bothell, Washington)

Company

hirify.global is an independent technology consulting firm providing solutions to over 1000 clients globally across 60 countries.

What you will do

• Identify and remediate gaps between user needs, design requirements, and verification/validation evidence.
• Author design control documentation, including DFMEA, PFMEA, UFMEA, and Risk Management Matrices.
• Build and repair end-to-end requirements traceability from regulatory requirements through to product documentation.
• Develop V&V test protocols ensuring compliance with FDA and ISO design control requirements.
• Prepare remediated documentation for migration into CodeBeamer or other ALM platforms.
• Track remediation activities and program metrics using Azure DevOps.

Requirements

• Degree in Biomedical, Systems, Mechanical, Electrical Engineering or a related discipline.
• 3–7+ years of experience in medical device product development within a regulated design controls environment.
• Strong experience with ISO 14971 risk management (DFMEA, PFMEA, UFMEA).
• Proven experience authoring V&V protocols, reports, and traceability documentation.
• Knowledge of FDA Design Controls (21 CFR 820.30) and ISO 13485.
• English: Professional fluency (C1) required.
• Location: Must be based in or able to work in Bothell, Washington (Hybrid).

Culture & Benefits

• International community comprising more than 110 different nationalities.
• Strong internal growth culture where 70% of leaders started at the entry level.
• Access to a comprehensive training system via the internal Academy.
• Dynamic work environment with frequent internal team-building and social events.

Hiring process

• Brief virtual or phone introductory call.
• Average of 3 interviews with line managers and team members.
• Potential technical assessment or case study.