Impactful Medical Device Risk Engineer (Hybrid)

Sitka Inc.; Phoenix (AZ); Hybrid; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

Gore is seeking an experienced Product Risk Management Engineer to lead risk assessments for product and manufacturing processes. The role focuses on risk-based decision making to ensure product safety and the maintenance of Risk Management File sections of the Design History File.

Location may be in Flagstaff or Phoenix, Arizona with a hybrid option and relocation support. Ideal candidates will drive quality improvements while collaborating with cross-functional teams to ensure regulatory

Qualifikationen

• Bachelor's degree required in engineering, science or technical field.
• 5+ years of experience in product risk management processes.
• Experience with structured problem-solving (8D/PDCA) for root cause analysis.
• Familiarity with global medical device regulations and standards (ISO13485, ISO14971, 21 CFR Part 803/820).

Aufgaben

• Own product line risk management files and documentation per ISO and global regulatory requirements.
• Support investigations to address product/process issues and improve performance.
• Collaborate with engineers across development cycles (scale-up, validation, improvement).
• Ensure quality management system documentation supports design and development planning.
• Assess risk from design changes, manufacturing events, and post-market surveillance.
• Periodically review Risk Management File documents to reflect data and trends.
• Promote and maintain risk management processes for medical devices globally.
• Lead changes to Risk Management Files due to standards or regulatory updates.
• Maintain consistency of Risk Management Files across product lines.
• Demonstrate equitable and inclusive behavior within the team.

Kenntnisse

Risk management

8D problem solving

Statistical analysis

Cross-functional collaboration

Communication

Travel readiness

Ausbildung

Bachelor’s degree in engineering, science or technical field

Tools

ISO 14971

ISO 13485

FDA 21 CFR Part 803/820

Jobbeschreibung

Gore is seeking an experienced Product Risk Management Engineer to lead risk assessments for product and manufacturing processes. The role focuses on risk-based decision making to ensure product safety and the maintenance of Risk Management File sections of the Design History File.

Location may be in Flagstaff or Phoenix, Arizona with a hybrid option and relocation support. Ideal candidates will drive quality improvements while collaborating with cross-functional teams to ensure regulatory