Manufacturing Technician (Mechanical)

The Manufacturing Technician is a senior hands-on role responsible for the assembly, testing, packaging, and troubleshooting of Class III medical devices in compliance with documented procedures, quality standards, and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14644). In addition to performing complex assembly and inspection tasks, the Manufacturing Technician will: Set up, calibrate, and maintain manufacturing equipment. Perform in-process quality verification and troubleshooting. Support new product introduction and process validation. Mentor and train Product Builders / Operators in best practices. 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 the advancement of BiVACOR's innovative cardiovascular technology, requiring precision and attention to detail. KEY RESPONSIBILITIES Manufacturing Perform complex assemblies, repairs, inspections, and/or test operations following detailed instructions. Proactively identifies and communicates quality issues and concerns Record information on approved documents Perform equipment setup, calibration, preventive maintenance, and minor repairs (as applicable) Conduct in-process functional tests and mechanical/electrical checks Troubleshoot assembly, equipment, and process issues to identify root causes and support implementation of corrective actions Support engineering teams with prototype builds, design verification, and process validation activities. Quality Compliance Maintain training proficiency and certifications to remain in compliance Maintain compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) Complete production records, batch documentation, and device history records accurately and in real-time. Immediately report deviations, non-conformances, or equipment malfunctions to supervisors. Assist in implementing corrective and preventive actions (CAPAs) Maintain a culture of quality and accountability throughout the operations organization. Operational Excellence & Continuous Improvement Suggest process improvements to enhance efficiency, quality, and safety. Participate in training programs to maintain knowledge of current procedures and regulatory requirements. Collaborate effectively with production, quality, and engineering teams Operations Support Perform operations support tasks as required, e.g., receiving, inventory handling, or shipping. QUALIFICATIONS AND EXPERIENCE Exceptional attention to detail and commitment to product quality. Strong focus on safety, cleanliness, and regulatory compliance. Ability to work both independently and as part of a team. Self-motivated, able to work independently, and take initiative in problem-solving Good communication skills for effective collaboration and reporting. Strong manual dexterity and hand-eye coordination, patience and care in handling delicate components. Proficiency in communication and understanding of English, including reading work instructions to consistently build defect-free medical products Qualifications Associate degree in Manufacturing Technology, Engineering, or related technical field, 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. Preferred Experience in Class III medical device assembly or other high-risk medical products. Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14644 standards. Familiarity with process validation, IQ/OQ/PQ documentation, and NPI (new product introduction) Prior use of microscopes, precision measurement tools, and test equipment. Experience working in a cleanroom environment. Experience with Lean Manufacturing and related principles, and working directly with the engineers to make continuous improvement changes. Physical Requirements • Sit and/or stand for extended periods of time as needed • Fine motor skills for precise assembly tasks. • Capability to lift and move up to 25 lbs when needed. • Willingness to wear cleanroom attire (gown, gloves, mask, etc.) for entire shifts. • Work overtime as required 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 developed by Daniel Timms who continues to collaborate with various researchers and institutes in Australia. Our highly driven and performing team has complementary science and business minds to focus on "Replacing Hearts and Restoring Lives." Today, BiVACOR has a robust collaborative network that extends nationally and internationally and boasts a team of world-class engineers, medical specialists, and business executives fervent to advance this ground-breaking technology. Core to us and our culture is collaboration, working hard and recognizing those around us. BiVACOR is an equal opportunity employer. We are committed to creating an inclusive environment for all employees. Our employment decisions are based on individual qualifications, job requirements and business needs without regard to race, color, marital status, sex, sexual orientation, gender identity and/or expression, age, religion, disability, citizenship status, national origin, pregnancy, veteran status and or any other legally protected characteristics. We are committed to providing reasonable accommodation, if you need an accommodation to complete the application process, please email View email address on click.appcast.io . Our Benefits and Perks Health and Welfare Medical Benefits – Numerous HMO and PPO options, several of which have monthly premiums fully employer funded. Dental/Vision, Short-term & Long-term Disability also available at low employee cost. Vacation and PTO BiVACOR also has very generous vacation and PTO policies. Vacation policy for first year employees is 80 hours per year. Increasing yearly up to 136 hours upon 7th year of employment. In addition to vacation, we also have a PTO policy equaling an additional 80 hours of time off per year. 401(k) BiVACOR proudly offers both Non-Elective and Elective 401(k) plans. Our Non-Elective 401(k) is a 4% employer only contribution, made on your behalf each pay period and immediately vested upon 90-day qualification. Our Elective 401(k)-employer match is up to 6%. That means that for every dollar you contribute to your 401 (k), you will receive a matching dollar-for-dollar contribution in your account up to 6% of your pay. Incentives Short-Term and Long-Term Incentives are also part of our current benefit package. #J-18808-Ljbffr