Abbott Sr. Specialist - Clinical Cath Lab in Westford, Massachusetts
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.
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.
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.
RT, RN, or RCIS certification or degree
4-5 yr recent catheter lab experience (coronary + endovascular ideal)
Willingness to travel up to 40% (including international)
Willingness to train to on-the-job skill sets:
Simulated catheter lab product testing during product development
Strong writing skills (protocols/reports) in Microsoft Word
Strong verbal communication skills
Interpersonal skill set interfacing with physicians
Familiarity operating fluoroscopy unit and operating in fluoroscopy/sterile environment
Experience as a scrub technician during procedures
Experience working with medical device Quality systems and/or regulatory product approval processes
Experience with Microsoft Office products, including Powerpoint for presentations and Excel for data analysis
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. 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com