Principal Clinical Engineer

locationsUnited States - California - SylmarUnited States - California - Sunnyvaletime typeFull timeposted onPosted 10 Days Agojob requisition id31121167Abbott 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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: 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 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 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 This position works onsite in our Sylmar, CA or Sunnyvale, CA locations in the Cardiac Rhythm Management Division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. What You'll Work On Leads by example as the clinical engineering lead responsible for major programs accountable for clinical risk burn down and program technical execution.Owns pre-defined tasks within a larger effort such as user need and feature definition, validation or product development of a sub-system, and drives them to on-time, high quality completion.Leads investigation and definition clinical requirements for new product/feature development and facilitates the translation into new projects through clinical review and evaluation. Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.Organizes and manages work to deliver clinical engineering deliverables on programs; leads and mentors other clinical engineers or other external resources in the execution of assigned work.Reports significant progress and final findings of projects to management and product development staff in the company.Gathers and analyzes input requirements for medical devices, supporting instrumentation/service infrastructure, and translates these into specific system requirements/interface specifications. Identifying potential product enhancements and new product ideas by applying an analytical approach to understanding the clinical needs of physicians and usersSimulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers' intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies.Develops and directs preclinical evaluation protocols, data analysis, and reportsContributes to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.Collaborating with other organizations within the company as needed: engineering, regulatory, human factors, quality, marketing, etcProvides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Performs other related duties and responsibilities, on occasion, as assigned. Required Qualifications Domain knowledge of cardiac rhythm management (CRM) devices strongly preferredBS Degree in biomedical, mechanical, electrical, or similarMinimum of 10+ years of clinical medical device experience or equivalent, ideally with CRM productsExperience in leading within matrix organizations requiring strong influence management skillsAbility to travel approximately 10%, including internationally.Preferred Qualification and EducationMaster's or Doctoral Degree in biomedical, mechanical or electrical engineering, or a biological or physical science or medicineProfessional training/education certification in CRM productsDomain knowledge of cardiac rhythm management (CRM) devices strongly preferredAdvanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.Fluent in medical procedure terminology and sound knowledge of cardiac anatomyMedical device experience preferred Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews. The base pay for this position is $146,700.00 – $293,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Product Development DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Sylmar : 13150 Telfair Avenue ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: