Principal Clinical Advisor, Clinical Engineering

Thornton Tomasetti; Temecula (CA); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Health care programs

Paid time off

401(k) retirement plan

Job summary

Abbott seeks a Principal Clinical Advisor, Clinical Engineering to support clinical knowledge across product development, bench testing, and evaluations in multiple locations including Temecula, CA.

You will contribute to risk analysis, IFU writing, and health hazard assessments, collaborating with physicians and engineers while supporting recalls and field actions.

Qualifications

• Bachelor's degree plus 7+ years of related work experience
• RT, RN or RCIS certification or related catheter lab experience preferred
• Experience with medical device quality systems and regulatory processes

Responsibilities

• Provide clinical knowledge to bench testing and device evaluations
• Create clinical performance evaluation plans and interact with physicians and engineers
• Write device Instructions For Use (IFU) and contribute to risk analysis
• Participate in product action process and Health Hazard Assessments
• Support decision making on recalls or field actions with clinical input
• Develop staff and mentor junior team members
• Collaborate across locations to achieve project goals

Skills

Communication

Verbal skills

Interpersonal skills

MS Office

Education

Bachelor's degree

RT/RN/RCIS certification

Tools

PowerPoint

Excel

Job description

Principal Clinical Advisor, Clinical Engineering

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.

• 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 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

• 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.

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.

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

Abbott welcomes and encourages diversity in our workforce.

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.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.