Risk Management Engineer

Responsibilities

• Provide risk management expertise across remediation workstreams.
• Review design documentation to ensure appropriate consideration of product risk.
• Support retrospective evaluation of risk within design documentation.
• Afford assistance in developing risk-based justifications where documentation gaps exist.
• Ensure risk considerations are incorporated during documentation updates and remediation activities.
• Offer guidance on alignment with risk management expectations under QMSR and ISO 14971.
• Collaborate with cross-functional teams to ensure risk perspectives are appropriately integrated.

Qualifications

• Experience in risk management within medical device development.
• Experience supporting remediation initiatives within regulated environments.
• Familiarity with risk management principles and methodologies.
• Experience applying or reviewing risk processes aligned with ISO 14971.
• Familiarity with risk management expectations under FDA QMSR and global regulatory frameworks.
• Experience reviewing design documentation with risk considerations.

Skills

N/A

Benefits

N/A

Pay

N/A

Schedule

N/A