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. 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! #J-18808-Ljbffr WorkTrybe