Manufacturing Engineer III
About the role
The Manufacturing Engineer III 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, ensuring high-quality, cost-effective manufacturing while maintaining regulatory and performance standards for implantable components. The Manufacturing Engineer III 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.
Responsibilities
- 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.
- Design, procure, and validate equipment, tools, and fixtures for manufacturing processes.
- Ensure proper calibration and maintenance of manufacturing equipment.
- Conduct process validations (IQ, OQ, PQ) and ensure compliance with FDA, ISO 13485, and GMP standards.
- Support NC/CAPA investigations and implement corrective actions.
- Create and maintain manufacturing documentation, including BOMs, work instructions, and process flow charts.
- Prepare technical reports and documentation for audits and regulatory submissions.
- 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)
- 5+ years engineering experience including skills in process development, Manufacturing Engineering and industrialization preferably in the medical device industry or other highly regulated industry
- Expert in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs.
- A working knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations.
- Working knowledge of industry best practices and applicable standards.
- Advanced problem-solving (Six Sigma Green / Black Belt)
Qualifications
- BS in Mechanical, Electrical, Biomedical or Manufacturing Engineering, MS desirable (or equivalent)
- 5+ years engineering experience including skills in process development, Manufacturing Engineering and industrialization preferably in the medical device industry or other highly regulated industry
- Expert in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs.
- A working knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations.
- Working knowledge of industry best practices and applicable standards.
- Advanced problem-solving (Six Sigma Green / Black Belt)
Skills
- Expertise in process characterization, pFMEAs, MVP, IQ / OQ / PQ / PPQ, and TMVs.
- Knowledge of medical device quality regulations, practices and quality standards, such as ISO 13485 and FDA quality system regulations.
- Working knowledge of industry best practices and applicable standards.
- Advanced problem-solving (Six Sigma Green / Black Belt)
Benefits
- BiVACOR offers a competitive compensation package and comprehensive benefits, including: 401(k) with company matching, Medical, dental, and vision insurance, Health Savings Account (HSA) & Flexible Spending Account (FSA), Life insurance & Employee Assistance Program, Generous paid time off.
Pay
The expected salary range for this position is $120,000 to $127,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Schedule
This role is based on-site at BiVACOR’s Huntington Beach headquarters.