Principal Clinical Advisor, Clinical Engineering

Abbott•Saint Paul, MN

About The Position

Abbott is seeking a Principal Clinical Advisor, Clinical Engineering for its St. Paul, Minnesota; Santa Clara, California; or Temecula, California location. The role provides clinical knowledge, expertise, and direction relevant to manufacturing, quality, product performance, and patient safety throughout product development, helping ensure informed decisions. Abbott Vascular develops minimally invasive, cost-effective products for vascular disease, including stents, guide wires, balloon dilatation and imaging catheters, software, and vessel closure devices. The advisor supports product development through clinical input to bench testing, in-vitro and/or in-vivo device evaluations, and development of test methods. The role also develops clinical performance evaluation plans, writes device Instructions for Use, contributes to risk analysis and product-action assessments, and provides clinical input to recall or field-action decisions. The position requires extensive collaboration and networking, guidance for less experienced staff, participation in project goals and objectives, and judgment in solving technical or business problems. The role operates in a quality-system environment and may involve international travel of up to 30–50%. This is a full-time position with a posted base pay range of $99,300 to $198,700; pay may vary by location. The work shift is listed as standard. The posting identifies prolonged sitting and standing as significant work activities.

Requirements

Bachelor's degree and 7 or more years of related work experience with a strong understanding of the relevant functional area, or an equivalent combination of education and work experience.
RT, RN, or RCIS certification or degree.
Four to five years of recent catheter lab experience; coronary and endovascular experience is ideal.
Solid understanding and application of business concepts, procedures, and practices.
Willingness to travel up to 30–50%, including internationally.
Ability to work in a quality-system environment where inadequate performance could result in noncompliance with governmental regulations.

Nice To Haves

Certification in a related field or health industry combined with work experience may be considered.
Demonstrated ability and willingness to learn new technical and clinical skill sets.
Experience with simulated catheter lab product testing during product development.
Strong writing skills, including preparation of protocols and reports.
Strong verbal communication skills.
Interpersonal skills for interfacing with physicians.
Familiarity with operating a fluoroscopy unit and working in a fluoroscopy or sterile environment.
Experience as a scrub technician during procedures.
Experience 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.

Responsibilities

Contribute clinical knowledge to bench testing, perform in-vitro and/or in-vivo device evaluations, and assist in developing new test methods to improve understanding of device performance.
Create clinical performance evaluation plans to assess physician acceptance and expected product performance, coordinating with physicians, engineers, clinical coordinators, regulatory affairs, and other personnel.
Write device Instructions for Use (IFU).
Participate in risk analysis for new or improved devices to identify and appropriately analyze potential patient risks associated with device use.
Perform and document Health Hazard Assessments for the Product Action process and communicate assessments to Quality Assurance.
Contribute clinical perspective to product recall or field-action decisions by attending Product Action committee meetings, summarizing clinical feedback, conducting product testing as needed, and providing clinical expertise.
Establish and cultivate a support network to facilitate completion of assignments.
Support development of less experienced staff by setting an example, providing guidance, and offering counsel.
Participate in determining project goals and objectives.
Influence middle management on technical or business solutions.
Use judgment to select innovative, practical methods for resolving problems.

Benefits

Career development and growth opportunities.
Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
Retirement savings plan with a high employer contribution.
Tuition reimbursement.
Freedom 2 Save student debt program.
FreeU education benefit and an affordable path to earning a bachelor's degree.
Training and onboarding programs for new employees.
Competitive compensation and incentives.
Medical, dental, and vision coverage.
Wellness and occupational health programs.
Paid time off.
401(k) retirement savings plan with a generous company match.