Staff Risk Management Engineer

Abbott Laboratories • Plymouth, MN

100d • $97,300 - $194,700

About The Position

The Staff Risk Management Engineer position at Abbott is based in Plymouth, MN, within the Electrophysiology Medical Device division. This role is crucial in ensuring that new products perform safely and comply with quality systems. The engineer will collaborate with various functions including clinical, design engineering, regulatory, labeling, and post-market surveillance to effectively manage and mitigate risks associated with medical devices. The position emphasizes maintaining strong partnerships with cross-functional teams to protect patient safety and meet business objectives.

Requirements

• Bachelor level degree in Engineering or Technical Field.
• 8+ years of experience in a relevant field.
• Previous design quality engineering experience with quality tools/methodologies.

Nice To Haves

• Advanced Degree.
• Prior medical device experience.
• Working understanding of FDA, GMP, and ISO 13485.
• Familiarity with standards such as ISO14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and ISO 14155.
• Systems or clinical engineering experience.
• Experience with basic statistics and reliability methodologies.
• Experience facilitating risk assessments (e.g., FMEAs or FTAs).

Responsibilities

• Support and execute risk management plans for product development.
• Assist in the requirements development process to ensure quality and linkage to risk management files.
• Conduct system hazard analysis and risk assessments (FTAs, FMEAs).
• Analyze and incorporate legacy inputs and coordinate cybersecurity risk with patient safety implications.
• Maintain traceability among hazards, risks, risk analyses, evaluations, and risk controls.
• Write system/product risk management reports.
• Track and develop responses to post-market signals and lead risk management file updates.
• Conduct complaint analysis and related action planning.
• Develop proficiencies in primary risk assessment tools (e.g., FMEA, FTA).
• Identify opportunities for improvement in risk management processes.
• Support CAPA efforts linked to Risk Management Process.

Benefits

• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and Freedom 2 Save student debt program.
• Recognition as a great place to work and for diversity.
• Fast-paced work environment with a focus on safety.
• Training and career development programs.
• Health care and well-being programs including medical, dental, vision.
• Paid time off and 401(k) retirement savings with generous company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree