Medical Device Systems 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

We are seeking a Medical Device Design Controls & Remediation Engineer to support a structured FDA remediation program for a portfolio of released oral healthcare products. This role is focused on closing gaps across Requirements Engineering, Risk Management, and Verification & Validation (V&V) through documentation remediation, traceability reconstruction, and risk analysis activities. The successful candidate will work closely with Quality, Regulatory, Engineering, and Program teams to strengthen design control records and prepare compliant deliverables for migration into an ALM platform.

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.

Preferred Qualifications

• Direct experience supporting FDA remediation, CAPA, inspection responses, or 483 observation closure activities.
• Knowledge of IEC 62304, electrical or thermal safety standards (IEC 60601, IEC 62368), and ALM migration projects involving Windchill and CodeBeamer.