Medical Device Design Controls Remediation Engineer

Mantu; Bothell (WA); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Mantu is seeking a Medical Device Design Controls & Remediation Engineer to support a structured FDA remediation program for a portfolio of released oral healthcare products. The role will close gaps in Requirements Engineering, Risk Management, and V&V through documentation remediation and traceability reconstruction.

The successful candidate will author and update design control documents, develop verification protocols, and migrate remediated records into ALM platforms such as CodeBeamer,

Qualifications

• Bachelor’s or Master’s degree in Biomedical, Systems, Mechanical, or Electrical Engineering.
• 3–7+ years in medical device product development within a regulated design controls environment.
• Strong ISO 14971 risk management experience including DFMEA, PFMEA, UFMEA, and RMM.
• Experience authoring verification/validation protocols, reports, requirements specs, and traceability docs.
• Knowledge of FDA Design Controls / 21 CFR 820.30, ISO 13485, and ALM tools such as CodeBeamer, Polarion, IBM DOORS, or Windchill.
• Excellent technical writing, analytical, organizational, and communication skills; fluent in English; able to work in a cross-functional hybrid environment.

Responsibilities

• Identify and remediate gaps between user needs, design requirements, risk analyses, and verification/validation evidence across medical device product families.
• Author and update design control documentation, including requirements specifications, DFMEA, PFMEA, UFMEA, RMM, and V&V 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 (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

Regulatory compliance

Technical writing

Analytical thinking

Cross-functional collaboration

Education

Biomedical/Systems/Mechanical/Electrical Engineering degree

Tools

CodeBeamer

Polarion

IBM DOORS

Windchill

Job description

Mantu is seeking a Medical Device Design Controls & Remediation Engineer to support a structured FDA remediation program for a portfolio of released oral healthcare products. The role will close gaps in Requirements Engineering, Risk Management, and V&V through documentation remediation and traceability reconstruction.

The successful candidate will author and update design control documents, develop verification protocols, and migrate remediated records into ALM platforms such as CodeBeamer,