JRG Partners is proud to partner with a premier, globally recognized leader in the medical device industry to identify a transformative Chief Operating Officer (COO). Our client, headquartered in the vibrant technology hub of Irvine, California, is renowned for its innovation, commitment to quality, and dedication to improving patient outcomes worldwide. This is a rare and career-defining opportunity for a seasoned operational executive to step into a pivotal leadership role, shaping the future of a dynamic and rapidly growing organization.
As the COO, you will be the strategic partner to the Chief Executive Officer (CEO), responsible for the entire spectrum of the company’s operations. You will translate the company’s vision and long-term strategy into actionable, efficient, and scalable operational plans. This role demands a leader with a profound understanding of the medical device landscape, a passion for operational excellence, and the ability to inspire high-performing teams across multiple functions and geographies. You will be the driving force behind our client’s ability to scale manufacturing, optimize a complex global supply chain, and maintain the highest standards of quality and regulatory compliance in a highly competitive market.
Role Overview for Chief Operating Officer with a Global Medical Device Co. – Irvine, CA
The Chief Operating Officer will serve as a key member of the executive leadership team, reporting directly to the CEO. This individual will have comprehensive oversight of all operational functions, including Manufacturing, Supply Chain, Logistics, Quality Assurance, Regulatory Affairs, and Program Management. The ideal candidate is a results-oriented leader with a proven track record of driving significant improvements in efficiency, productivity, and profitability within a regulated, high-growth environment. You will be instrumental in building a world-class operational infrastructure that supports the company’s ambitious growth trajectory, new product introductions, and global market expansion. Your leadership will ensure that the organization is agile, resilient, and consistently delivers on its promise of providing life-changing medical technologies to patients and healthcare providers around the world. This role requires a unique blend of strategic foresight, tactical execution, financial acumen, and inspirational leadership to foster a culture of continuous improvement and accountability.
Key Responsibilities of Chief Operating Officer with a Global Medical Device Co. – Irvine, CA
The COO’s responsibilities are broad and critical to the success of the organization. You will be expected to master the following areas:
Strategic Leadership & Execution
- Collaborate with the CEO and executive team to develop and implement the company’s strategic vision, business plans, and operational goals.
- Translate strategic objectives into measurable operational metrics and key performance indicators (KPIs) for all departments under your purview.
- Lead the annual operational planning and budgeting process, ensuring alignment with the company’s financial and strategic targets.
- Evaluate and manage operational risks, developing contingency plans to ensure business continuity and resilience.
- Drive key corporate initiatives, including potential M&A integration, technology implementations, and major capital projects.
Operational Excellence & Process Improvement
- Champion a culture of continuous improvement by implementing Lean Manufacturing, Six Sigma, and other operational excellence methodologies across the organization.
- Identify and eliminate bottlenecks, inefficiencies, and waste in all operational processes to enhance productivity and reduce costs.
- Oversee the implementation of new technologies and systems (e.g., ERP, MES) to streamline operations and improve data-driven decision-making.
- Establish and monitor performance benchmarks to ensure all operational functions meet or exceed industry best practices.
Manufacturing & Supply Chain Management
- Direct all manufacturing operations, ensuring the safe, efficient, and high-quality production of medical devices in compliance with all regulatory standards.
- Develop and execute a global supply chain strategy that optimizes inventory management, sourcing, procurement, and logistics.
- Build and maintain strong relationships with key suppliers and contract manufacturing organizations (CMOs) to ensure reliability, quality, and cost-effectiveness.
- Oversee demand planning, production scheduling, and capacity planning to meet fluctuating market demands and support new product launches.
Quality Assurance & Regulatory Compliance
- Provide executive oversight for the Quality Management System (QMS), ensuring robust compliance with all applicable domestic and international regulations.
- Ensure strict adherence to global regulatory standards, including the FDA’s Quality System Regulation (21 CFR Part 820), ISO 13485, and other relevant medical device directives.
- Lead the organization through regulatory inspections and audits, fostering a culture of audit-readiness at all times.
- Collaborate with the R&D and Clinical teams to ensure regulatory requirements are integrated throughout the product lifecycle.
Team Leadership & Development
- Lead, mentor, and develop a high-performing team of operational leaders, fostering a culture of collaboration, accountability, and innovation.
- Establish clear goals and expectations for your direct reports and their respective teams, providing regular feedback and performance management.
- Champion talent development and succession planning within the operations organization to build a strong leadership pipeline.
- Foster a positive and inclusive work environment that attracts, retains, and motivates top talent.
Requirements for the Chief Operating Officer with a Global Medical Device Co. – Irvine, CA
We are seeking a candidate who meets the following qualifications and possesses the essential attributes to excel in this demanding role:
Education & Experience
- Bachelor’s degree in Engineering, Business Administration, Operations Management, or a related field is required. An MBA or other advanced degree is strongly preferred.
- A minimum of 15-20 years of progressive leadership experience in operations within the medical device, pharmaceutical, or another highly regulated industry.
- At least 10 years of experience in a senior leadership role (e.g., VP of Operations, General Manager, COO) with P&L responsibility.
- Demonstrated experience managing complex, multi-site, global manufacturing and supply chain operations.
- Proven track record of successfully scaling operations in a high-growth company environment.
- Experience with M&A due diligence and post-merger integration is highly desirable.
Skills & Competencies
- Deep and comprehensive knowledge of FDA regulations (21 CFR 820), ISO 13485, and Good Manufacturing Practices (GMP).
- Expertise in operational excellence methodologies such as Lean Manufacturing, Six Sigma, and Total Quality Management (TQM).
- Exceptional financial acumen with experience managing large budgets, capital expenditures, and driving cost-saving initiatives.
- Strong analytical and problem-solving skills, with the ability to make sound, data-driven decisions in a fast-paced environment.
- Outstanding leadership and interpersonal skills, with a proven ability to influence, inspire, and build consensus across all levels of an organization.
- Excellent written and verbal communication skills, with the ability to present complex information clearly and concisely to diverse audiences, including the Board of Directors.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive executive compensation and benefits package, including:
Competitive Executive Salary
A highly attractive base salary commensurate with experience and market standards.
Performance-Based Bonus
A significant annual bonus plan tied to individual and company performance.
Equity/Long-Term Incentives
A substantial equity package to ensure alignment with the long-term success of the company.
Comprehensive Health Coverage
Premium medical, dental, and vision insurance for you and your eligible dependents.
Retirement Savings
A robust 401(k) plan with a generous company match.
Generous Paid Time Off
A flexible and generous PTO policy, including vacation, sick days, and paid holidays.
Relocation Assistance
A comprehensive relocation package is available for the right candidate.
Professional Development
Support for continuing education, executive coaching, and attendance at industry conferences.
Work-Life Balance
A commitment to fostering a healthy and supportive work environment.
How to Apply
JRG Partners is exclusively managing this confidential search. If you are a visionary operational leader with the experience and drive to make a significant impact on a global scale, we encourage you to apply.
To be considered for this exceptional opportunity, please submit your resume and a cover letter outlining your qualifications and interest in the role. For more information about our expertise in this sector, please visit our Medical Device & Diagnostics practice area page.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
