Medical Device Assembler

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.

• 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.

• 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.

• 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.

• 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.

• 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!