Manufacturing Engineering Technician III- Medical Devices
Job in
Huntington Beach, Orange County, California, 92615, USA
Listed on 2026-03-01
Listing for:
BiVACOR Inc.
Full Time
position Listed on 2026-03-01
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Medical Device Industry, Validation Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Medical Device Industry, Validation Engineer
Job Description & How to Apply Below
Manufacturing Engineering Technician III - Medical Devices
Engineering Technician needed to support a regulated Class III medical device program ds‑on role. Career development & growth on offer.
FullJob Description
- Help bring BiVACOR’s Total Artificial Heart from engineering into compliant production.
- Hands‑on role supporting equipment, validation, and low‑volume manufacturing in a regulated environment.
- Onsite in Huntington Beach, CA. $35–39/hour + benefits.
- Set up, operate, maintain, and troubleshoot manufacturing and test equipment.
- Support equipment and process validations (IQ, OQ, PQ).
- Perform routine equipment maintenance and calibration to ensure reliability and uptime.
- Build and test medical devices in compliance with work instructions and environmental controls.
- Develop and support assembly and test fixtures.
- Inspect supplier components and finished devices against quality documentation.
- Troubleshoot product and process issues and contribute to root‑cause investigations.
- Support process improvements alongside manufacturing and quality engineers.
- Assist with creation and maintenance of work instructions, drawings, and manufacturing documentation.
- Maintain accurate records to support FDA, ISO 13485, and GMP compliance.
- Provide technical support and training to operators on equipment and processes.
- Associate degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or equivalent hands‑on experience.
- 3+ years’ experience in manufacturing, assembly, or production within medical devices, aerospace, or other heavily regulated manufacturing environments.
- Strong hands‑on experience with equipment setup, maintenance, and troubleshooting.
- Experience working in FDA/ISO‑regulated manufacturing environments.
- Comfortable working independently with a quality‑first mindset.
- Strong attention to detail and documentation.
- Enthusiastic to learn and develop; a Junior Engineer can start in this role and grow.
- Work on a life‑sustaining Class III medical device.
- Hands‑on role with real impact on patient outcomes.
- Close collaboration with engineering, quality, and operations teams.
- Onsite role in Huntington Beach, CA.
- Competitive hourly rate with benefits.
- Be part of a mission‑driven team changing the future of cardiac care.
Bring your technical expertise to a purpose‑driven organization and be part of changing lives for the better. Apply now!
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