Abbott
healthcare
RiskManagementEngineerII
“Risk Management Engineer II at Abbott. Skills: Risk Management, Quality Engineering, ISO 14971, ISO 13485. 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”
Industry & Context.
risk is appropriately mitigated, evaluated, disclosed, and monitored
up to 10% travel, 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)
What They're Looking For.
Must Have
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., organizational and follow-up skills, as well as attention to detail.
Nice to Have
Knowledge of Complaint Handling process, Working knowledge of EUMDR requirements, Experience with basic statistics, Clinical engineering experience
What You'll Do.
Support Risk Management activities from product concept through product obsolescence.
Support creation of risk mitigation strategy and establishment of objective
and verifiable customer and product requirements to meet that strategy
Create and update Risk Management Plans
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 Notified / Regulatory Body inquiries
Complete Document Change Request Reviews in a timely and objective manner
How You'll Work.
Team & Collaboration
collaborate with Clinical Engineering, Research & Development, Regulatory Affairs, Labeling, and Post-Market Surveillance functions; maintaining a collaborative partnership with cross-functional team members
Communication Scope
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Process & Methodology
prioritizes, meets deadlines in timely manner
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