Biomedical Engineering
Principal Biomedical Engineer
Lexington, KY
$120,000 to $153,000 a year
The employer is a diagnostics company building lab instruments and point-of-care test systems.
As a Principal Biomedical Engineer with the employer, you will set technical direction and help shape how the biomedical engineering team works. This position is based in Lexington, KY. This is a full-time, permanent position. This role is on site at our Lexington location.
What you’ll do
- Maintain risk management files
- Write verification and validation protocols and reports
- Design and develop medical devices under design controls
- Support regulatory submissions
- Work with clinicians to gather user needs
- Mentor junior engineers and review their work
- Set technical standards and guide decisions across multiple projects
What you’ll bring
- Bachelor’s degree in Biomedical or Mechanical Engineering
- 8+ years of relevant professional experience
- Experience writing test protocols
- Experience in a regulated medical device environment
- Knowledge of ISO 13485 and FDA design controls
- A track record of leading projects from scope through delivery
Nice to have
- Experience with Class II or Class III devices
- Experience with 510(k) submissions
Compensation and benefits
The pay range for this position in Lexington, KY is $120,000 – $153,000 per year. Final pay depends on experience, skills and qualifications.
- Employee assistance program
- Health savings account with employer contribution
- Flexible spending accounts
- Short- and long-term disability insurance
- Medical, dental and vision insurance starting on day one
- Life insurance
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.
