Medical Device Design Controls & Remediation Engineer

Amaris Consulting; Bothell (WA); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Global training program

Industry-leading academy

Team events and international team

Job summary

Amaris Consulting in Bothell, WA seeks dynamic Life Sciences consultants to help remediate design control gaps and drive regulatory-compliant verification across medical device families. You will author and update DFMEA/PFMEA/UFMEA, manage risk analyses, and ensure traceability from business needs to verification evidence, using leading ALM tools.

Candidates bring 3–7+ years in regulated medical device development, strong writing and cross-functional collaboration skills, and fluency in English

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.

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.

Skills

ISO 14971 risk management

Technical writing

English fluency

Cross-functional collaboration

3-7+ years medical device experience

Education

Bachelor’s or Master’s degree in Biomedical, Systems, Mechanical, or Electrical Engineering

Tools

CodeBeamer

Polarion

IBM DOORS

Windchill

Job description

Amaris Consulting in Bothell, WA seeks dynamic Life Sciences consultants to help remediate design control gaps and drive regulatory-compliant verification across medical device families. You will author and update DFMEA/PFMEA/UFMEA, manage risk analyses, and ensure traceability from business needs to verification evidence, using leading ALM tools.

Candidates bring 3–7+ years in regulated medical device development, strong writing and cross-functional collaboration skills, and fluency in English