Principal Clinical Advisor, Clinical Engineering

Thornton Tomasetti; Saint Paul (MN); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Paid Time Off

Retirement Plan

Job summary

Abbott, a global healthcare leader, seeks a Principal Clinical Advisor in Clinical Engineering to support manufacturing, quality, and patient safety across development stages. The role will be based in Saint Paul, MN, with potential travel to other Abbott sites.

The position requires a Bachelor’s degree and 7+ years of related experience, with RN/RT/RCIS certification and catheter lab exposure. Strong writing and communication skills are essential.

Qualifications

• Bachelor's degree plus 7+ years of related work experience or equivalent.
• RT, RN, or RCIS certification or degree with catheter lab experience.
• Experience with medical device quality systems and regulatory processes.
• Willingness to travel up to 30–50% (including international).
• Strong writing and verbal communication skills.

Responsibilities

• Support product development with clinical knowledge for bench testing and device evaluations.
• Create clinical performance evaluation plans and interact with physicians and engineers.
• Write device Instructions For Use (IFU).
• Participate in Risk Analysis for new or improved devices.
• Contribute clinical perspective to Product Action and quality decisions.
• Develop staff and mentor junior colleagues.
• Assist in setting goals for projects and influencing decisions.

Skills

Clinical knowledge

Verbal communication

Writing skills

Interpersonal skills

Fluoroscopy familiarity

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 Demonstrated ability and willingness to learn new technical and clinical skill sets.
• Simulated catheter lab product testing during product development.
• Strong writing skills (protocols/reports).
• 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.

WHAT WE OFFER

• At Abbott, you can have a good job that can grow into a great career.
• 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 > Minnesota > St. Paul : 1225 Old Highway 8 NW ADDITIONAL LOCATIONS: United States > Santa Clara : Building A - SC 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter