Post-Market Risk & Reliability Engineer II

Planet Pharma; Mounds View (MN); On-site; USD 90,000 - 140,000; Full time

Job summary

Planet Pharma seeks a Technical Specialist to support post-market risk response for Affera hardware products. Ideal candidates bring risk management and change control experience in medical devices.

You will lead risk assessment activities, apply HRA, draft deliverables, and coordinate with medical safety and cross-functional teams to close gaps and ensure CAS-compliant files. Responsibilities include conducting reliability studies, CAPA support, design of experiments, and lab testing as needed

Qualifications

• Baccalaureate degree in engineering, life sciences or related field.
• Minimum 2 years of relevant risk management or post-market experience in medical devices.
• Experience with risk assessment, HRA, CAS procedures, and CAPA processes.

Responsibilities

• Supports post-market risk response and risk management remediation for Affera hardware products.
• Performs risk assessment, HRA, and initiates PHO or FCA as needed.
• Updates hazards and hazardous situations to CAS procedures; drafts deliverables and leads reviews.
• Coordinates with medical safety and cross-functional partners to close gaps and ensure CAS compliance.
• Supports change orders and CAPA activities; conducts lab testing for investigations (DV/TMV) as needed.

Skills

Risk management

Change control

Post-market surveillance

HRA

CAPA

Lab testing

Reliability engineering

DOE

Education

Bachelor's degree

Master's degree

Job description

Planet Pharma seeks a Technical Specialist to support post-market risk response for Affera hardware products. Ideal candidates bring risk management and change control experience in medical devices.

You will lead risk assessment activities, apply HRA, draft deliverables, and coordinate with medical safety and cross-functional teams to close gaps and ensure CAS-compliant files. Responsibilities include conducting reliability studies, CAPA support, design of experiments, and lab testing as needed