Hands‑on role assembling, testing and packaging medical devices, based onsite in Huntington Beach, CA. Pay $28‑34/hr depending on experience.
Build a device that saves lives.
What The Role Involves
- Precision Manufacturing & Assembly: Assemble, inspect, test, and package complex medical devices using detailed work instructions.
- Quality & Regulatory Compliance: Work in compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14644, GMP, GDP. Complete batch records and device history records. Report deviations immediately. Maintain training certifications.
- Operational Excellence & Continuous Improvement: Suggest and support process improvements. Participate in training, audits, and new product introduction activities. Collaborate closely with Manufacturing, Quality, Engineering.
- Operations Support (as needed): Assist with inventory handling, receiving, and shipping activities. Follow proper material handling and hazardous waste disposal procedures.
What We’re Looking For
- 1‑2+ years of experience in manufacturing or assembly (medical device highly preferred).
- Exceptional attention to detail and pride in craftsmanship.
- Strong manual dexterity, hand‑eye coordination, patience, steady hands.
- Ability to follow detailed written instructions and produce defect‑free builds.
- Self‑motivated, reliable, and comfortable working independently or in a team.
- Clear communication skills and strong understanding of written and spoken English.
- Commitment to safety, cleanliness, and compliance.
- High‑school diploma or equivalent.
- Experience documenting work accurately and consistently.
Preferred Experience (Nice to Have)
- Class III medical device or other high‑risk product assembly.
- Cleanroom manufacturing experience.
- Familiarity with FDA QSR, ISO 13485, ISO 14644.
- Exposure to process validation (IQ/OQ/PQ) and NPI.
- Use of microscopes, precision measurement tools, and test equipment.
- Lean Manufacturing or continuous improvement participation.
Physical & Work Requirements
- Ability to sit and/or stand for extended periods.
- Fine motor skills for detailed assembly tasks.
- Ability to lift up to 25 lbs.
- Willingness to wear cleanroom attire for full shifts.
- Flexibility to work overtime when required.
Why Join BiVACOR?
- Be part of a mission‑driven team building truly life‑saving technology.
- Work in a clean, modern, highly regulated manufacturing environment.
- Collaborate with engineers and experts at the forefront of cardiovascular innovation.
- Competitive hourly pay with opportunity to grow alongside a rapidly advancing medical technology company.
- Full‑time hours – 8 am‑5 pm (with some flexibility on start/finish times).
- Awesome benefits including PTO, vacation time.
If this role sounds like you please apply now!