Principal R&D Engineer

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 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 your family, be your true self, and live a full life. Youll 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 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 bachelors degree. A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Santa Clara, CA location. We are recruiting a Principal R&D Engineer to join our Ventures organization to support our clinical trials and commercialization stages of our transcatheter mitral valve replacement (TMVR) system. This role will serve as the technical clinical interface within R&D, owning product performance from a design perspective, and ensuring that field feedback is translated into compliant, riskbased engineering solutions. The individual will lead IFU ownership, customer requirements, human factors activities, sustaining design changes, and fielddriven investigations, including root cause analysis and redesign efforts resulting from failures, complaints, and clinical feedback. This is a highly visible role requiring deep understanding of clinical use, regulatory expectations, and crossfunctional execution. Hiring Manager: Lior Noyovitch What Youll Work On Own the Instructions for Use (IFU), ensuring technical accuracy, usability, traceability to design inputs, and alignment with clinical practice and risk mitigations. Translate customer, physician, and clinical feedback into clear, testable user needs and design requirements. Lead Human Factors Engineering (HFE) activities, including usability risk assessments, formative studies, summative validation, and postmarket usability updates. Serve as an R&D technical owner for field issues, complaints, and failures, supporting investigation activities and ensuring design accountability. Execute and lead root cause analyses using structured problemsolving methodologies (e.g., fault trees, fishbone, DOE). Drive sustaining design changes to maintain and improve MTVR system performance, safety, and usability in response to field data and complaint trends. Support redesign efforts by partnering with design, quality, regulatory, and manufacturing to implement compliant, corrective, and preventive actions. Manage external test laboratories, including biocompatibility, sterilization, packaging, and revalidation activities. Ensure alignment of design changes with regulatory submissions, risk management file updates, and Design History File (DHF) documentation. Partner crossfunctionally with Clinical, Quality, Regulatory, Medical Affairs, and Manufacturing Operations to ensure timely and compliant issue resolution. Required Qualifications Bachelors degree in engineering or related technical field (mechanical, biomedical, or equivalent). Minimum 810 years of medical device development experience, including sustaining or postmarket engineering surveillance. Experience with structural heart or transcatheter cardiovascular devices. Demonstrated experience working under Design Controls and ISO 13485 / FDA QSR environments. Experience owning or supporting IFUs, user needs, or human factors engineering for Class III medical devices. Proven ability to conduct root cause analysis and support fielddriven corrective actions. Strong written and verbal communication skills, including the ability to translate clinical feedback into engineering actions. Ability to work independently, prioritize multiple issues, and lead crossfunctional technical efforts. Preferred Qualifications Direct exposure to field action support, complaints investigations, or postmarket surveillance. Familiarity with human factors standards (IEC 62366), risk management (ISO 14971), and related FDA guidance. Experience supporting regulatory submissions related to design changes or field corrections. Experience working closely with clinicians, clinical engineers, or medical affairs teams. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com 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 www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $114,000.00 $228,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: SH Structural Heart LOCATION: United States > Santa Clara : Building B - SC ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % 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 its 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 lifes 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