Staff R&d Engineer

Abbott

Santa Clara, California, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
Product performance ownership
Clinical trials support
Commercialization support
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

Job Summary

  • 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.
  • Abbott offers career development with an international company, excellent benefits including medical coverage and retirement savings, and educational assistance programs.

Matching Summary

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.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings, tuition reimbursement

Skills & Requirements

Must-have

  • product performance ownership
  • clinical trials support
  • commercialization support
  • root cause analysis
  • sustaining design changes
  • cross-functional partnership

Nice-to-have

  • technical clinical interface
  • risk-based engineering solutions
  • customer requirements translation
  • post-market usability updates
  • structured problem-solving methodologies

Key Requirements

  • Bachelor's degree in engineering or related technical field
  • 8-10 years medical device development experience
  • Experience with structural heart or transcatheter cardiovascular devices
  • Experience under Design Controls and ISO 13485 / FDA QSR
  • Experience owning IFUs, user needs, or human factors for Class III devices
  • Proven ability to conduct root cause analysis
  • Ability to work independently and lead cross-functional efforts

Work Rights

Not specified

Tailored Resume

Cover Letter