Staff 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 115,000 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. 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 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. 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 Staff 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, risk‑based engineering solutions.  The individual will lead IFU ownership, customer requirements, human factors activities, sustaining design changes, and field‑driven 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 cross‑functional execution.  Hiring Manager: Lior Noyovitch  What You’ll 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 post‑market 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 problem‑solving 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 re‑validation activities.  Ensure alignment of design changes with regulatory submissions, risk management file updates, and Design History File (DHF) documentation.  Partner cross‑functionally with Clinical, Quality, Regulatory, Medical Affairs, and Manufacturing Operations to ensure timely and compliant issue resolution.  Required Qualifications Bachelor’s degree in engineering or related technical field (mechanical, biomedical, or equivalent).  Minimum 8–10 years of medical device development experience, including sustaining or post‑market 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 field‑driven 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 cross‐functional technical efforts.  Preferred Qualifications Direct exposure to field action support, complaints investigations, or post‑market 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