Director of Site Operations

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 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.

Role Overview

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.

Key Responsibilities: Site & Facility Management

• 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

Production Operations

• 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

Team Leadership & Workforce Development

• 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

Quality & Regulatory Compliance

• 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

Manufacturing Scale-Up & Continuous Improvement

• 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

Qualifications: Required

• 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

Preferred

• 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

What Makes This Role Unique

• You will be building the manufacturing operation for the world’s first durable total artificial heart, a device with the potential to save tens of thousands of lives annually

• BiVACOR has completed successful first-in-human implants, is in process of completing its EFS trial ahead of pivotal start, and holds FDA Breakthrough Device Designation and is part of the FDA’s exclusive TAP program for highest priority devices

• The manufacturing operation is complex, with multiple subassemblies, external suppliers, precision titanium components, magnetic levitation systems, hermetic welding, biocompatible coatings, and rigorous regulatory requirements

• You will have significant influence on strategic decisions including insourcing vs. outsourcing, facility expansion, capital equipment and long-term site strategy

• You will join a senior operations team with deep domain expertise from top-tier cardiovascular and medical device companies

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

The expected salary range for this position based in Huntington Beach California is $150,000 - $231,000. Actual pay 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.