Sr Reliability Engineer

Sr. Risk Engineer responsible for driving and maintaining medical device risk management activities across Class III products. Focus is on ISO 14971 compliance, design controls, and cross-functional risk collaboration throughout the product lifecycle.

• Maintain and update Risk Management Files for medical devices
• Perform hazard analysis, FMEA, risk evaluation, and mitigation tracking
• Ensure risk controls are implemented, verified, and validated
• Collaborate with Design, Human Factors, Reliability, Safety, and Post-Market teams
• Assess and document patient safety and product performance risks
• Support design control deliverables (DV/PV, usability, design transfer, specs)
• Drive risk process consistency and continuous improvement across projects
• Communicate risk findings to leadership and stakeholders

• 3+ years ISO 14971 experience in medical devices
• Experience maintaining risk management files (Class III preferred)
• Strong knowledge of design controls / quality design deliverables
• Experience with hazard analysis, FMEA, risk assessment

• Implantable or complex medical devices
• FDA 21 CFR 820, ISO 13485, EU MDR knowledge
• Statistics / risk quantification methods
• Human factors / usability engineering exposure

• Strong cross-functional collaboration & consensus building
• Attention to detail and documentation accuracy
• Ability to evaluate and communicate patient risk impacts
• Leadership in risk discussions and decision-making support

Ensuring medical devices are safe, compliant, and risk-controlled throughout design and development by managing ISO 14971-based risk files and working closely with engineering and quality teams.