Biomedical Engineering
Senior Biomedical Engineer
Irvine, CA
$141,000 to $180,000 a year
The employer is a health technology company building software and devices for outpatient care.
The employer is looking for a Senior Biomedical Engineer in Irvine, CA. In this role you will lead technical work alongside an experienced biomedical engineering team and take real ownership of your work. This is a full-time, permanent position. This role is on site at our Irvine location.
What you’ll do
- Support regulatory submissions
- Maintain risk management files
- Write verification and validation protocols and reports
- Design and develop medical devices under design controls
- Work with clinicians to gather user needs
- Mentor junior engineers and review their work
What you’ll bring
- Bachelor’s degree in Biomedical or Mechanical Engineering
- 5+ years of relevant professional experience
- Knowledge of ISO 13485 and FDA design controls
- Experience writing test protocols
- Experience in a regulated medical device environment
- A track record of leading projects from scope through delivery
Nice to have
- Experience with 510(k) submissions
- Experience with Class II or Class III devices
Compensation and benefits
The pay range for this position in Irvine, CA is $141,000 – $180,000 per year. Final pay depends on experience, skills and qualifications.
- Health savings account with employer contribution
- Short- and long-term disability insurance
- Life insurance
- Medical, dental and vision insurance starting on day one
- 401(k) with company match
- Flexible spending accounts
The employer is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
