Senior Medical Device Risk Manager (Hybrid/Remote)

Warwick Consulting Limited; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Travel opportunities

Job summary

Warwick Consulting Limited is seeking an experienced Senior Risk Management Engineer to lead risk management for medical device capital equipment across the product lifecycle, including design, development, manufacturing, commercialization, and post‑market activities. The role requires hands‑on experience with hazard analyses, risk controls, residual risk evaluation, and regulatory compliance.

You will collaborate with Engineering, Quality, Regulatory Affairs, R&D, and Manufacturing, with

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum 7+ years of relevant experience in medical device risk management, product safety, quality engineering, systems engineering, or a closely related discipline.
• Demonstrated experience with medical device capital equipment, preferably complex electromechanical systems or integrated hardware and software.
• Strong knowledge of ISO 14971 and FDA QMSR requirements and their application to medical device risk management.
• Hands-on experience with FMEA, FTA, and risk-based assessment methodologies.
• Experience developing and maintaining risk management plans, hazard analyses, risk management files, and reports.
• Ability to establish traceability between hazards, risk controls, verification evidence, and residual risk evaluations.
• Experience collaborating with Engineering, Quality, Regulatory Affairs, and cross-functional technical teams.
• Willingness and ability to travel internationally when required.

Responsibilities

• Lead risk management activities for medical device capital equipment across design, development, manufacturing, and post‑market phases.
• Develop, review, and maintain risk management plans, analyses, files, and reports in accordance with ISO 14971 and regulatory requirements.
• Apply FMEA, FTA, and RBA methodologies to identify hazards, analyze failure modes, evaluate risks, and establish mitigation strategies.
• Evaluate the effectiveness of risk controls, including residual risk and acceptability.
• Facilitate risk assessments involving mechanical, electrical, software, and integrated systems.
• Assess complaints, nonconformances, CAPAs, design changes, and post‑market information for impact on safety.
• Integrate risk management into design controls, verification/validation, change management, and lifecycle processes.
• Prepare and maintain risk management documentation and traceability.

Skills

ISO 14971

FDA QMSR

FMEA

FTA

RBA

Design controls

Hazard analysis

Risk communication

Education

Bachelor's degree in Engineering or Biomedical Engineering

Job description

Warwick Consulting Limited is seeking an experienced Senior Risk Management Engineer to lead risk management for medical device capital equipment across the product lifecycle, including design, development, manufacturing, commercialization, and post‑market activities. The role requires hands‑on experience with hazard analyses, risk controls, residual risk evaluation, and regulatory compliance.

You will collaborate with Engineering, Quality, Regulatory Affairs, R&D, and Manufacturing, with