Engineer Technician III

The Engineering Technician is a hands‑on role responsible for supporting the development, improvement, and scaling of assembly and test processes for a Class III medical device. The Engineering Technician will help bridge between design and production by executing validations, maintaining equipment, documenting processes, and supporting pilot and low‑volume manufacturing operations. This role will work closely with Mechanical, Electrical, and Biomedical Engineers, Quality, and Operations to deliver and scale a regulated medical product in a fast‑paced environment.

This role requires strong technical skills, a quality‑first mindset, and the ability to work independently under minimal supervision.
This hands‑on role contributes to advancing BiVACOR’s innovative cardiovascular technology and requires precision and attention to detail.

KEY RESPONSIBILITIES

Equipment Maintenance & Calibration

Set up, operate, and maintain production and test equipment in accordance with manufacturing instructions and quality standards.

Support equipment qualifications (IQ/OQ/PQ), process validations, and test method validations.

Perform routine maintenance and calibration of manufacturing equipment to ensure optimal performance.

Troubleshoot and resolve equipment issues to minimize downtime.

Build products whilst complying with environmental controls, hygiene, procedures, and work instructions.

Develop assembly and test fixtures in accordance with work instructions.

Inspect supplier components against quality inspection documentation.

Test, inspect, and measure finished products, components, and devices to verify compliance with functional specifications, using established procedures, work instructions, and test protocols.

Troubleshoot, adjust, or repair, and perform root cause analysis on finished products, components, or parts.

Process Support

• Assist in the development and optimization of manufacturing processes.
• Support engineers in implementing process improvements to enhance efficiency and reduce costs.
• Assist quality and purchasing team with maintenance of inventory logs.
• Assist engineers with the creation, modification, review, and processing of work instructions, assembly drawings, processes, protocols, reports, records, and design change orders.

Quality Assurance

Conduct inspections and tests on products and components to ensure they meet quality standards.

Document and report any non‑conformances or defects to the engineering team.

Contribute to failure analysis and root cause investigations (e.g., NCRs, CAPAs).

Ensure cleanroom or controlled manufacturing areas meet housekeeping, ESD, and 5S requirements.

Documentation and Compliance

Maintain accurate records of equipment maintenance, calibration, and process changes.

Ensure compliance with FDA, ISO 13485, and GMP standards in all activities.

• Work closely with manufacturing engineers, quality teams, and production staff to support daily operations.
• Provide technical assistance and training to operators on equipment and processes.

QUALIFICATIONS AND EXPERIENCE

Skills & Experience

• Associate Degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or equivalent experience.
• Minimum 3+ years of experience in manufacturing, assembly, or production—preferably in medical devices, pharmaceuticals, or other regulated industries.
• Demonstrated ability to follow detailed instructions and document work accurately.
• Strong verbal and written communication skills.

BiVACOR ® is a clinical stage medical device company developing the BiVACOR Total Artificial Heart (TAH), the first long‑term therapy for patients with severe heart failure. The TAH is designed to replace the complete function of the native heart and address the global unmet need of patients with end‑stage heart failure (HF) by providing a next generation life‑extending solution.

Headquartered in Huntington Beach, CA and with an international office in Brisbane, Australia, BiVACOR was founded in 2008 by a team of internationally renowned biomedical engineers and cardiac surgeons, including Chief Technical Officer, Daniel Timms, PhD and Chief Medical Officer, William Cohn, MD. The original IP was…