Principal Clinical Advisor, Clinical Engineering

Abbott; Santa Clara (CA); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health care and well-being programs

Tuition reimbursement

401(k) retirement savings with company

Paid time off

Career development and onboarding

Job summary

Abbott is seeking a Principal Clinical Advisor, Clinical Engineering in Temecula, CA (or other Abbott locations) to apply clinical knowledge across manufacturing, quality, and patient safety during product development. The role supports bench testing, in‑vivo/vitro evaluations, and risk analyses.

Responsibilities include creating clinical evaluation plans, writing IFUs, and contributing to product actions and recalls with cross-functional teams.

Qualifications

• Bachelor’s degree or equivalent with 7+ years in a related field.
• RT, RN, or RCIS certification.
• 4–5 year recent catheter lab experience (coronary + endovascular ideal).
• Willingness to travel up to 30-50% (including international).

Responsibilities

• Provide clinical knowledge to bench testing and device evaluations.
• Develop clinical performance evaluation plans and interface with physicians and engineers.
• Write device Instructions For Use (IFU).
• Participate in Risk Analysis to identify patient risks.
• Contribute clinical perspective to Product Action decisions and recalls.

Skills

Clinical knowledge

Communication skills

Writing skills

Interpersonal skills

Leadership

Education

Bachelor's degree

RT/RN/RCIS certification

Catheter lab experience

Tools

Microsoft Office

PowerPoint

Excel

Job description

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 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Title

Principal Clinical Advisor, Clinical Engineering

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career of which you dream.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

THE OPPORTUNITY

We are seeking a Principal Clinical Advisor, Clinical Engineering to work in one of the following Abbott locations: St Paul, MN, Santa Clara, CA or Temecula CA. The Principal Clinical Advisor, Clinical Engineering will 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.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

WHAT YOU’LL DO

• 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.

• Create 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).

• Write device Instructions For Use (IFU).

• Participate 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 the Product Action process by performing and documenting a Health Hazard Assessment and communicating the assessment to Quality Assurance.

• Contribute 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.

• Establish and cultivate an extensive network of support to facilitate completion of assignments.

• Participate in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

• Participate in determining goals and objectives for projects.

• Influence middle management on technical or business solutions.

• Exercise judgment in selecting innovative, practical methods to achieve problem resolution.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree plus 7+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience preferred. Will consider certification in related field or health industry with combined work experience.
• RT, RN, or RCIS certification or degree
• 4-5 year recent catheter lab experience (coronary + endovascular ideal)
• 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.
• Willingness to travel up to 30-50% (including international)

Preferred

• Willingness to train to on-the-job skill sets:
• Simulated catheter lab product testing during product development
• Strong writing skills (protocols/reports)
• Strong verbal communication skillsInterpersonal 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

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority
• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

$99,300.00 – $198,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

AVD Vascular

LOCATION:

United States > Temecula : Building E - TE

ADDITIONAL LOCATIONS:

United States > Minnesota > St. Paul : 1225 Old Highway 8 NW

WORK SHIFT:

Standard

TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf