JOB DESCRIPTION:Risk Management Engineer II The Opportunity Structural Heart
Structural Heart Business Mission: Why We Exist
Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
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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.
What You'll Do- 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
- Additional duties may be identified by functional management based on the current project/business objectives, including up to 10% travel.
Required Qualifications:- 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.
Preferred Qualifications:- Knowledge of Complaint Handling process
- Working knowledge of EUMDR requirements
- Experience with basic statistics
- Clinical engineering experience
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is $61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:SH Structural Heart
LOCATION:United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
