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.

**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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-stude...) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree...) 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, testableuser needs and design requirements.

+ **Lead** Human Factors Engineering (HFE) activities, including usability risk assessments, formative studies, summative validation, and post‑market usability updates.

+ **Serve** asanR&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** tomaintainand 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 implementcompliant,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 ensuretimelyand compliant issue resolution.

**Required Qualifications**

+ Bachelor’s degree inengineeringorrelatedtechnical field (mechanical, biomedical, or equivalent).

+ Minimum8–10 yearsof medical device development experience, includingsustaining or post‑market engineeringsurveillance.

+ Experience withstructural heart or transcatheter cardiovascular devices.

+ Demonstrated experience working underDesign ControlsandISO 13485 / FDA QSRenvironments.

+ Experience owning or supportingIFUs, user needs, or human factors engineeringfor Class III medical devices.

+ Proven ability to conductroot cause analysisand 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 leadcross‐functional technical efforts.

**Preferred Qualifications**

+ Direct exposure tofield action support, complaints investigations, or post‑market surveillance.

+ Familiarity withhuman factors standards(IEC 62366),risk management(ISO 14971), and related FDA guidance.

+ Experience supportingregulatory submissionsrelated to design changes or field corrections.

+ Experience working closely with clinicians, clinical engineers, or medical affairs teams.

Apply Now (https://www.jobs.abbott/us/en)

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com