Manufacturing Engineering II (Mechanical)

The Manufacturing Engineer II plays a crucial role in developing, optimizing, and implementing efficient and scalable manufacturing processes for the BiVACOR total artificial heart (TAH). This position focuses on integrating value engineering principles to ensure high-quality, cost-effective manufacturing while maintaining regulatory and performance standards. The Manufacturing Engineer II collaborates with engineering teams, management, and external vendors to improve tooling and component quality, evaluate cost-reduction strategies, and implement process improvements that enhance the long-term viability and manufacturability of the device. The role involves testing, troubleshooting, and optimizing production processes to ensure that the product conforms to specifications. KEY RESPONSIBILITIES Process Development and Optimization Design, develop, and improve manufacturing processes to enhance efficiency and product quality. Implement Lean and Six Sigma methodologies to reduce waste and optimize workflows. Implement automation and advanced manufacturing techniques where applicable. Equipment and Tooling Design, procure, and validate equipment, tools, and fixtures for manufacturing processes. Ensure proper calibration and maintenance of manufacturing equipment. Validation and Compliance Conduct process validations (IQ, OQ, PQ) and ensure compliance with FDA, ISO 13485, and GMP standards. Support NC/CAPA investigations and implement corrective actions Documentation and Reporting Create and maintain manufacturing documentation, including BOMs, work instructions, and process flow charts. Prepare technical reports and documentation for audits and regulatory submissions. Problem Solving and Continuous Improvement Analyze and resolve manufacturing issues, including CAPAs and non-conformances. Identify opportunities for process improvements and implement solutions to enhance productivity and reduce costs. Work closely with cross-functional teams, including R&D, Quality Assurance, and Supply Chain, to support product development and manufacturing goals. Provide technical support to production teams and train operators on new processes and equipment. REQUIREMENTS BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering, MS desirable (or equivalent) 2 – 4 years of engineering experience, including skills in process development, Manufacturing Engineering and industrialization, preferably in the medical device industry or other highly regulated industry A working knowledge of process characterisation, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs is desirable. An understanding of medical device quality regulations, practices, and quality standards, such as ISO 13485 and FDA quality system regulations. Familiarity with industry best practices and applicable standards. Familiarity with LEAN principles and practices. While performing the duties of this job, the employee is regularly required to perform light material handling tasks involving lifting weights of up to 35 pounds for short durations. This position requires sitting for extended periods, up to and sometimes exceeding 8 hours a day. Duties will also involve keyboard data entry. SALARY RANGE: $85,000 – $95,000 annually 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 hr@bivacor.com . 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.

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