Risk Management Engineer II

Abbott • St. Paul, MN

4d • Onsite

About The Position

The Risk Management Engineer II assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with Clinical Engineering, Research & Development, Regulatory Affairs, Labeling, and Post-Market Surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will be at our Woodridge location in Minnesota.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or other technical fields
• 2-5 years’ experience in Medical Devices, preferably with Class III implantable cardiovascular products
• Previous Quality Engineering, Risk Management experience
• Working knowledge of ISO 14971 and ISO 13485 standards
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to work in a matrixed and geographically diverse business environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Knowledge of Complaint Handling process
• Working knowledge of EUMDR requirements
• Experience with basic statistics
• Clinical engineering experience

Responsibilities

• Support Risk Management activities from product concept through product obsolescence.
• Support creation of risk mitigation strategy and establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
• Create and update Risk Management Plans, Hazard Analyses, c/d/p/uFMEAs, and Risk Management Reports
• Ensure verification and validation evidence supports the planned risk mitigation strategy
• Maintain Risk Management File to ensure continued acceptability of product based on post market feedback
• Support CAPAs
• Support Notified / Regulatory Body inquiries
• Complete Document Change Request Reviews in a timely and objective manner

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level