Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
A Risk Management Engineer assures new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system. They collaborate with clinical, design engineering, regulatory, 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.
Execute and support on-time completion of Risk Management Deliverables. Ability to support highly complex or specialized projects
Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
Ensure verification and validation evidence supports the planned risk mitigation strategy
Complete Document Change Request Reviews in a timely and objective manner
Mentor engineers on risk management within the quality organization
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor level degree in Engineering or Technical Field, advance degree preferred
Working knowledge of ISO14971
10+ years' experience
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model
Working understanding of FDA, GMP, and ISO 13485
Working understanding of the following standards: 60601, 62304, and/or 62366
Systems or clinical engineering experience
Experience with basic statistics and/or reliability methodologies
Project Management experience
DIVISION:CAHF Cardiac Arrhythmias & Heart Failure
LOCATION:United States > Sylmar : 15900 Valley View Court
ADDITIONAL LOCATIONS:United States > Sunnyvale : 645 Almanor Ave
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
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)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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