Biomedical Manufacturing Engineer – ICU Medical
ICU Medical develops, manufactures, and sells medical devices used in infusion therapy, oncology, and critical care. Our San Clemente facility is looking for a Biomedical Manufacturing Engineer to support IV infusion and oncology device manufacturing operations.
Responsibilities
- Support manufacturing process development and validation for infusion devices
- Develop work instructions, SOPs, and process FMEAs for manufacturing lines
- Drive continuous improvement and lean manufacturing initiatives on the production floor
- Investigate manufacturing nonconformances and implement corrective actions
- Support equipment qualification (IQ/OQ/PQ) and process capability studies
- Collaborate with quality, regulatory, and product development on design transfers
Requirements
- BS in Biomedical Engineering, Industrial Engineering, or Mechanical Engineering
- 0-2 years experience in medical device manufacturing environment
- Familiarity with Lean, Six Sigma, or continuous improvement methodologies
- Understanding of FDA 21 CFR Part 820 and ISO 13485 manufacturing requirements
- Strong problem-solving skills and ability to work on production floor
Benefits
- Competitive salary and performance bonus
- Medical, dental, and vision insurance
- 401(k) plan with company match
- Generous paid time off policy
- Career development and internal mobility opportunities