30 days old

Senior Field Clinical Engineer

North Chicago, IL

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Primary Job Function:

Organize and conduct, or participate in, all performance evaluations for new products, product enhancements,
and product process changes. Participate as the clinical resource on product development teams, working with
R&D, Regulatory Affairs, Quality Assurance and Marketing in identifying user needs and market segments,
and presenting relevant evaluation results as necessary. Participate in Health Hazard Assessments, product
malfunctions and is a general clinical product resource to R&D.

Core Job Responsibilities:

· Provide clinical knowledge, expertise and direction relevant to manufacturing, quality, performance and
patient safety during all phases of development of a product or concepts to assure informed decisions are
made in these areas.
· Support product development by contributing clinical knowledge to bench testing, performing in-vitro and /or
in-vivo device evaluations and assisting in the development of new test methods to provide a better
understanding of device performance.
· Creates clinical performance evaluation plans to assess physician acceptance and the expected performance
of new products by interacting with appropriate personnel, (e.g., physicians, engineers, other clinical
coordinators, regulatory affairs).
· Writes device Instructions For Use (IFU).
· Participates in the Risk Analysis process for new or improved devices to ensure that potential risks to patients
associated with use of the device are identified and appropriately analyzed.
· Participates in Product Action process by performing and documenting a Health Hazard Assessment and
communicating the assessment to Quality Assurance.
Contributes clinical perspective to the decision making process regarding product recall or field action by
attending meetings with the Product Action committee, summarizing clinical feedback, performing product
testing as needed and providing general clinical knowledge and expertise.

Position Accountability / Scope:

Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Participates in the development of less experienced staff by setting an example, providing guidance, and
offering counsel.  May lead a project team.  Participates in determining goals and objectives for projects.
Influences middle management on technical or business solutions.  May interact with vendors. Exercises
judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or
erroneous decisions or recommendations would typically result in serious delays and considerable expenditure
of resources.

Minimum Education:

Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional
area, or an equivalent combination of education and work experience preferred. Consider certification in
related field or health industry with combined work experience.

Minimum Experience / Training Required:

Solid understanding and application of business concepts, procedures and practices. Will perform this job in a
quality system environment.  Failure to adequately perform tasks can result in noncompliance with
governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of
identifiable factors.  Exercises judgment within generally defined practices and policies in selecting methods
and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on
their business unit.
Job Family: Field Services
Division: MD Medical Devices
Travel: Yes, 75 % 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)


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Senior Field Clinical Engineer

North Chicago, IL

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North Chicago, IL

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