Role Overview for VP, Manufacturing Site Operations with a MedTech Company – Irvine, CA
JRG Partners is proud to partner with a pioneering medical technology company in their search for a dynamic and visionary Vice President of Manufacturing Site Operations. Based at their state-of-the-art facility in Irvine, California, this executive leadership role is pivotal to the company’s mission of delivering life-changing medical devices to patients worldwide. The successful candidate will assume full responsibility for the Irvine manufacturing site, steering all operational activities to achieve strategic goals related to safety, quality, delivery, and cost.
This is a rare opportunity to join a rapidly growing organization at a critical juncture. You will be instrumental in scaling operations, fostering a culture of continuous improvement, and ensuring the highest standards of regulatory compliance in a complex and rewarding industry. As the site leader, you will provide the strategic direction and hands-on leadership required to build high-performing teams, optimize production processes, and drive operational excellence across the board. You will be the linchpin connecting corporate strategy with on-the-ground execution, ensuring the Irvine facility not only meets but exceeds its performance targets. If you are a seasoned manufacturing executive with a passion for innovation and a proven track record of success within the MedTech space, we invite you to explore this career-defining role.
Key Responsibilities of VP, Manufacturing Site Operations with a MedTech Company – Irvine, CA
The VP of Manufacturing Site Operations will have a broad and impactful scope of responsibilities, including but not limited to:
Strategic Leadership & Site Management
- Develop and execute the site’s manufacturing strategy in alignment with corporate objectives, focusing on long-term growth, capacity planning, and technological advancement.
- Serve as the senior leader for the Irvine facility, fostering a positive, inclusive, and performance-driven culture that prioritizes safety and quality above all else.
- Champion a culture of continuous improvement, deploying Lean Manufacturing, Six Sigma, and other operational excellence methodologies to enhance efficiency, reduce waste, and improve product quality.
- Collaborate with the executive leadership team to set annual operating plans, budgets, and performance metrics (KPIs) for the site.
- Lead site-level strategic initiatives, including new product introductions (NPI), technology transfers, and facility expansions.
Operational & Production Excellence
- Direct and oversee all day-to-day manufacturing operations, including production, scheduling, materials management, engineering, and facilities maintenance.
- Ensure production schedules are met to satisfy customer demand while maintaining stringent quality standards and managing costs effectively.
- Implement and maintain robust systems for inventory control, supply chain management, and logistics to ensure an uninterrupted flow of materials and finished goods.
- Drive initiatives to optimize manufacturing processes, improve yields, reduce cycle times, and enhance overall equipment effectiveness (OEE).
- Oversee the site’s capital expenditure (CapEx) plan, identifying and justifying investments in new equipment, technology, and infrastructure to support growth and efficiency.
Quality & Regulatory Compliance
- Uphold the highest standards of quality and ensure the site operates in full compliance with all applicable regulations and standards, including FDA 21 CFR Part 820, cGMP, and ISO 13485 standards.
- Partner closely with the Quality Assurance department to maintain a robust Quality Management System (QMS), driving a ‘quality-first’ mindset throughout the organization.
- Act as the primary point of contact for regulatory audits (e.g., FDA, Notified Body), ensuring the site is audit-ready at all times and leading the response to any observations or findings.
- Oversee the investigation of non-conformances, implementation of corrective and preventive actions (CAPAs), and management of change control processes.
Team Development & Leadership
- Lead, mentor, and develop a high-caliber team of operational leaders, fostering professional growth and building a strong succession pipeline.
- Establish clear goals and expectations for direct reports and the entire site team, providing regular feedback, coaching, and performance management.
- Promote a culture of collaboration, accountability, and employee engagement, ensuring effective communication across all levels and departments of the site.
- Champion Environmental, Health, and Safety (EHS) programs, ensuring a safe and healthy work environment for all employees.
Requirements for the VP, Manufacturing Site Operations with a MedTech Company – Irvine, CA
The ideal candidate will be a results-oriented leader with extensive experience in medical device manufacturing and a deep understanding of the regulatory landscape.
Educational & Professional Experience
- Bachelor of Science degree in Engineering (Mechanical, Industrial, Biomedical), Operations Management, or a related technical field is required. A Master’s degree (MS or MBA) is highly preferred.
- A minimum of 15 years of progressive experience in a manufacturing environment, with at least 10 years in a significant leadership role (e.g., Director, Sr. Director, Plant Manager) within the medical device, pharmaceutical, or another highly regulated industry.
- Demonstrated experience managing a large-scale, complex manufacturing site, including P&L responsibility.
- Proven track record of successfully leading organizations through periods of significant growth, change, and process improvement.
- Hands-on experience with regulatory inspections and audits by the FDA and other international bodies.
Skills & Competencies
- In-depth knowledge of Quality Management Systems, cGMP, FDA regulations (21 CFR 820), and ISO 13485.
- Expertise in Lean Manufacturing, Six Sigma (Black Belt certification is a plus), and other continuous improvement methodologies.
- Strong financial acumen with experience in budgeting, forecasting, and cost management.
- Exceptional leadership and interpersonal skills with the ability to inspire, influence, and motivate teams at all levels of the organization.
- Excellent analytical, problem-solving, and decision-making abilities.
- Superior communication and presentation skills, with the ability to articulate complex concepts to both technical and non-technical audiences.
- Proficiency with ERP/MRP systems and other manufacturing software solutions.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a comprehensive and competitive compensation and benefits package. This includes:
Executive Compensation
A highly competitive base salary complemented by a significant annual performance-based bonus.
Equity Program
Meaningful long-term incentives, including stock options or restricted stock units (RSUs), allowing you to share in the company’s success.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Generous Paid Time Off
A competitive PTO policy, including vacation, sick leave, and paid company holidays, to support a healthy work-life balance.
Professional Development
A dedicated budget for continuous learning, including conferences, certifications, and executive coaching.
Relocation Assistance
A comprehensive relocation package is available for qualified candidates moving to the Irvine area.
Additional Perks
On-site amenities, wellness programs, and other employee-focused benefits.
How to Apply
This is an exclusive search being conducted by JRG Partners. If you are a transformative manufacturing leader ready to make a significant impact in the medical device industry, we encourage you to apply. To be considered for this confidential opportunity, please submit your resume and a cover letter outlining your qualifications and interest in the role.
JRG Partners specializes in connecting elite talent with leading companies in the life sciences sector. To learn more about our expertise and view other opportunities, please visit our Medical Device Recruiting practice area page. We look forward to reviewing your application.
