Principal Manufacturing Mechanical Engineer

Help Us Build the Future of the Human Heart. At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every process you optimize, every validation you lead, and every engineer you mentor plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here. About the Role The Principal Manufacturing Engineer 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. Key Responsibilities Champion Lean and Six Sigma methodologies, driving measurable waste reduction and a culture of continuous improvement across manufacturing Evaluate and implement automation and advanced manufacturing techniques to improve throughput, repeatability, and cost-effectiveness at scale Lead the design, procurement, and validation of equipment, tools, and fixtures to meet technical, regulatory, and production requirements Own process validation execution (IQ, OQ, PQ, PPQ), ensuring full compliance with FDA, ISO 13485, and GMP standards Lead NC/CAPA investigations and root cause analysis, implementing corrective and preventive actions that resolve systemic issues and prevent recurrence Manage complex, cross-functional manufacturing engineering projects from initiation through completion, ensuring on-time, on-budget delivery aligned with business objectives Define and enforce manufacturing engineering standards and design-for-manufacturability (DFM) guidelines across the product development lifecycle Shape manufacturing strategy and roadmap development, providing technical input on scale-up, technology transfer, and commercialization Serve as the senior manufacturing engineering voice in cross-functional collaboration with R&D, Quality, Supply Chain, and Regulatory teams during product development and design transfer Establish and maintain manufacturing documentation frameworks — BOMs, work instructions, process flow charts, and process controls — ensuring accuracy and regulatory readiness Author and review technical documentation for audits, regulatory submissions, and design history files, acting as subject matter expert during inspections What You Bring 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/PPQ, 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 What We Offer 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 This role is based on-site at BiVACOR’s Huntington Beach, California headquarters and reports to the Manufacturing Engineering Manager. The expected salary range for this position is $130,000 to $153,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Relocation benefits are not available for this posting. Apply today and be part of something extraordinary. BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.