Manufacturing Mechanical Engineer IV
About The Position
The Manufacturing Engineer IV is a senior technical leader responsible for driving the design, development, and continuous improvement of manufacturing processes for the BiVACOR Total Artificial Heart (TAH). Based at our Huntington Beach, California headquarters, this role serves as a subject matter expert in value engineering and advanced manufacturing, setting the technical direction to deliver high-quality, cost-effective, and scalable production solutions while upholding the highest regulatory and performance standards for implantable components. The Manufacturing Engineer IV leads cross-functional collaboration with R&D, Quality, and Supply Chain teams, as well as external partners, to elevate tooling and component quality and deliver sustained cost reduction. Beyond hands-on process ownership, this role carries significant technical leadership responsibilities, mentoring junior engineers, leading high-impact improvement initiatives, and contributing to the manufacturing strategy that supports the long-term commercialization of our device.
Requirements
- BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering; MS desirable (or equivalent experience)
- 8+ years of engineering experience with advanced skills in process development, Manufacturing Engineering, and industrialization; medical device or highly regulated industry experience strongly preferred
- Deep expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ, and TMVs, with a proven track record of owning and leading validation programs end-to-end
- Comprehensive knowledge of medical device quality regulations including ISO 13485 and FDA quality system regulations, with experience supporting regulatory submissions and audits
- Advanced problem-solving skills; Six Sigma Black Belt strongly preferred; formal project management training or certification (e.g., PMP) is an advantage
- Demonstrated experience leading cross-functional engineering projects and mentoring junior engineers; formal or informal people leadership experience is highly regarded
Responsibilities
- Lead the design, development, and strategic improvement of manufacturing processes, setting technical standards that enhance efficiency, scalability, and product quality across the BiVACOR TAH program.
- Champion Lean and Six Sigma methodologies across the manufacturing function, driving measurable waste reduction, workflow optimization, and a culture of continuous improvement
- Evaluate and implement automation and advanced manufacturing techniques, identifying opportunities to improve throughput, repeatability, and cost-effectiveness at scale
- Lead the design, procurement, and validation of equipment, tools, and fixtures, ensuring they meet technical, regulatory, and production requirements across the full product lifecycle
- Establish and oversee calibration and preventive maintenance programs, ensuring equipment reliability and compliance with GMP standards
- Own and lead the execution of process validations (IQ, OQ, PQ, PPQ) and ensure all manufacturing activities maintain full compliance with FDA, ISO 13485, and GMP standards
- Lead NC/CAPA investigations, drive root cause analysis, and implement robust corrective and preventive actions, ensuring systemic issues are resolved and recurrence is prevented
- Lead and manage complex, cross-functional manufacturing engineering projects from initiation through completion, ensuring on-time delivery, budget adherence, and alignment with business objectives
- Define and enforce manufacturing engineering standards, best practices, and design-for-manufacturability (DFM) guidelines across the product development lifecycle
- Contribute to manufacturing strategy and roadmap development, providing technical input to support product scale-up, technology transfer, and commercialization planning
- Lead cross-functional collaboration with R&D, Quality Assurance, Supply Chain, and Regulatory teams, acting as the senior manufacturing engineering voice in product development and design transfer activities
- Establish and maintain comprehensive manufacturing documentation frameworks, including BOMs, work instructions, process flow charts, and process controls, ensuring accuracy and regulatory readiness
- Author and review technical reports and documentation for audits, regulatory submissions, and design history files, serving as a subject matter expert during internal and external inspections
Benefits
- 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
- A discretionary annual bonus may be available based on individual and Company performance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
