The Vice President of Operations is a strategic executive responsible for leading the end-to-end operational strategy, including manufacturing, supply chain, procurement, and logistics. The ideal candidate will scale our production capabilities, optimize global supply chain resilience, and ensure uncompromising compliance with FDA, ISO 13485, and GMP regulations. This leader will bridge the gap between R&D, product development, and commercialization to deliver high-quality, cost-effective medical devices to the market
The ideal candidate will have a proven track record in Operations leadership, particularly in a medical device, medical technology or biotechnology organization. They will possess deep expertise in talent management, organizational development, and workforce planning.
This position is an office-based position at the company's Irvine, CA headquarters.
Responsibilities:
Strategic Leadership & Execution
• Translate corporate vision into actionable operational strategies, setting short- and long-term objectives for scaling manufacturing and supply chain.
• Oversee Profit & Loss (P&L) for the operations division, managing budgets, and identifying areas for continuous cost optimization.
• Serve as a core member of the executive leadership team, collaborating cross-functionally with R&D, Quality, Regulatory, and Commercial teams.
Program Management
• Lead end-to-end program execution across the organization, ensuring alignment with strategic goals and timelines
• Develop and implement standardized project management methodologies, tools, and reporting systems
• Monitor program performance metrics and proactively address risks, delays, and resource constraints
Manufacturing & Supply Chain Management
• Direct all manufacturing operations (internal facilities and/or outsourced/CMO partnerships), ensuring production schedules are met with the highest standards of safety and quality.
• Oversee global supply chain, procurement, and logistics, mitigating risks related to material shortages and distribution delays.
• Implement Lean Manufacturing and Six Sigma methodologies to eliminate waste, reduce lead times, and improve manufacturing efficiency.
Quality Assurance & Regulatory Compliance
• Partner closely with Quality/Regulatory to uphold and enforce compliance with FDA 21 CFR Part 820, ISO 13485, and other global regulatory requirements.
• Maintain a culture of compliance and continuous improvement, proactively addressing audits, CAPAs (Corrective and Preventive Actions), and non-conformances.
• Guarantee that all products are manufactured, tested, and released according to defined specifications.
New Product Introduction (NPI) & Scaling
• Partner closely with R&D during the design transfer phase to ensure new products are manufacturable, cost-effective, and ready for commercial scale.
• Manage capacity planning, facility expansions, and capital expenditure (CapEx) projects to support product pipeline growth.
• Build, mentor, and develop a high-performing operations team, fostering a culture of accountability, innovation, and operational excellence.
Requirements
Required Skills & Abilities
• Exceptional interpersonal and communication skills, with the ability to build trust across all levels of the organization.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making.
• Ability to navigate complexity and lead in a fast-paced, dynamic environment.
• Strategic thinker with a hands-on approach to operational excellence.
Education & Experience
• Bachelor's degree in Operations Management, Engineering (Biomedical, Mechanical, or Industrial), Business Administration, or a related technical field. Master's degree or MBA strongly preferred.
• Minimum of 15-20 years of progressive operations leadership experience in the medical device, life sciences, or heavily regulated manufacturing industry.
• Lifecycle Track Record: At least 5 years of experience in a startup or rapid-growth environment actively guiding a complex medical device through the transition from R&D to commercial launch.
• Product Complexity: Proven technical expertise managing Class II or Class III active (electromechanical) medical devices involving fluidics, software, or sterile disposables.
• Exceptional writing, editing, and verbal communication skills.
• Demonstrated expertise in talent management, organizational development, and Operations strategy.
• Proven success in managing change and leading cross-functional teams in a global setting.
Preferred Attributes:
• Deep expertise in Quality Management Systems (QMS), FDA regulations (cGMP), and ISO 13485.
• Strong track record of managing global or complex supply chains and contract manufacturing organizations (CMOs).
• Exceptional P&L management skills with proven ability to drive CapEx planning and cost-reduction initiatives.
• Proven capability to lead transformational change, manage risk, and foster cross-functional teamwork.
Travel
• Ability to occasionally travel domestically
Physical Requirements
• The employee may occasionally lift and/or move up to 25 pounds.
Working Environment:
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.
Salary Description
$225,000 - $260,000
