Director of Site Operations

BiVACOR Inc • Huntington Beach, CA

1d • Onsite

About The Position

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 validate, every fixture you design, and every challenge you overcome 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. The Director of Site Operations will be the senior on-site leader responsible for the day-to-day management and strategic development of BiVACOR’s Huntington Beach manufacturing facility. This role owns facility operations, production execution, supply chain, supplier management, workforce management, and operational readiness, ensuring the site can reliably produce life-sustaining devices to the highest standards of quality, safety, and regulatory compliance. This person will report to the VP of Operations & Manufacturing and work closely with supply chain, quality, engineering, and clinical operations leaders. They will be a key driver of BiVACOR’s transition from low-volume early-stage production to scalable, commercially ready manufacturing.

Requirements

• 10+ years of progressive experience in manufacturing operations, with at least 5 years in a site leadership or plant management role
• Direct experience in medical device manufacturing, strongly preferring Class III implantable or life-sustaining devices (cardiovascular, neuromodulation, structural heart, or similar)
• Deep working knowledge of FDA 21 CFR 820 (QSR), ISO 13485, and GMP requirements for medical devices
• Proven track record of scaling manufacturing from early/low-volume production to commercial volumes
• Experience managing cleanroom manufacturing environments (ISO Class 7–8)
• Strong background in production planning, capacity management, and supplier coordination in complex multi-site manufacturing networks
• Demonstrated ability to build and lead high-performing manufacturing teams in fast-paced, resource-constrained environments
• Bachelor’s degree in engineering, manufacturing, operations management, or related field

Nice To Haves

• Experience with PMA-class devices (cardiovascular devices such as LVADs, TAHs, heart valves, or similarly critical implantable/interventional devices in neurostimulation, neurovascular, etc.)
• Background in manufacturing transfer, new site start-up, or facility buildout for medical devices
• Experience strategic sourcing various manufacturing processes
• Familiarity with MRP/ERP system implementation and electronic batch record systems in a medical device context
• Experience supporting FDA IDE studies, pre-market submissions, or regulatory inspections from the manufacturing side
• Lean manufacturing, Six Sigma, or equivalent continuous improvement certification
• Master’s degree or MBA preferred but not required

Responsibilities

• Serve as the primary on-site operational leader for the Huntington Beach manufacturing facility, including cleanroom environments (ISO Class 7)
• Manage facility infrastructure, equipment maintenance, environmental monitoring, and EHS compliance
• Oversee facility expansion initiatives including cleanroom buildouts and potential satellite facility setup for expanded cleanroom capacity
• Ensure the site is always inspection-ready for FDA audits, ISO 13485 surveillance audits, and customer/investor visits
• Own execution of the production schedule, ensuring on-time delivery of pumps, controllers, and implantable accessories across all stages of build to meet business KPIs
• Manage a complex, multi-supplier manufacturing flow (machining, welding, coatings, sterilization) and expanding in-house operations
• Drive strategic sourcing initiatives
• Significantly reduce production lead times (post-machining) by eliminating non-value-added time
• Implement and manage production planning cadences including weekly production scheduling and S&OP processes
• Build, lead, and develop the site manufacturing team, including production technicians, assemblers, inspectors, and support staff, as the organization scales headcount
• Establish training programs, standard operating procedures, and skills matrices to ensure workforce readiness across all production processes
• Foster a culture of accountability, continuous improvement, and operational discipline appropriate for life-sustaining medical device manufacturing
• Coordinate with program management, supply chain, and quality leaders (both on-site and external consultants) to ensure cross-functional alignment
• Partner with Quality to maintain compliance with FDA 21 CFR 820, ISO 13485, and applicable EU MDR requirements
• Ensure device history records (DHRs), batch records, and production documentation meet regulatory standards and support traceability from raw material through sterilized, released product
• Own CAPA and nonconformance resolution on the production floor; drive root cause analysis and corrective actions
• Support transition from prototype-style documentation to production-ready electronic batch records and MRP-driven workflows
• Execute the manufacturing capacity plan to scale production, from current R&D production volume to commercial volume
• Identify opportunities to reduce lead times, optimize processes, and partner with R&D for design-for-manufacturing (DFM) opportunities
• Evaluate and champion capital equipment investments
• Support long-term facility strategy planning, including workforce projections, automation investments, and commercial-scale site considerations

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.
• Relocation benefits are not available for this posting

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees