Senior Clinical Engineer
Abbott
full-time
Posted on:
Location Type: Office
Location: Pleasanton • California, Vermont • 🇺🇸 United States
Visit company websiteSalary
💰 $75,300 - $150,700 per year
Job Level
Senior
About the role
- Represent clinical engineering on heart failure product development projects.
- Support product development efforts by performing clinical engineering tasks such as defining, investigating, analyzing, testing, and documenting activities associated with development of specific products.
- Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios.
- Investigate and define clinical and human factors requirements for new devices and system features, drive integration of features into the existing clinical workflows, and facilitate the transition of these features into products through clinical review and evaluation.
- Plan and execute feasibility studies, pre-clinical testing, technology assessments, benchmarking, and concept evaluations to inform design decisions.
- Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they address.
- Contribute to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments.
- Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and safety.
- Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission.
- Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Requirements
- Bachelor’s Degree in an Engineering discipline (Biomedical, Systems, Electrical, Mechanical, Software) or related discipline
- Minimum of 5 years of R&D experience in medical device development and/or other highly regulated industry. (Advanced degree may substitute for some experience.)
- Demonstrated ability to apply an expert understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects
- Demonstrated ability to effectively integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs.
- Demonstrated leadership in team settings, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Benefits
- Career development with an international company where you can grow the career you dream of.
- 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 a 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical engineeringproduct developmentfeasibility studiespre-clinical testingrisk managementclinical validationmedical device developmenttechnical assessmentsbenchmarkingregulatory compliance
Soft skills
leadershipcommunicationteam collaborationgoal settingconstructive feedbackproblem solvingrelationship buildingintegration of informationadaptabilitycritical thinking