Role Overview for Director of Manufacturing Systems Implementation with a MedTech Co. – Irvine, CA
JRG Partners is exclusively representing a pioneering medical technology company based in the heart of Irvine, California—a global hub for MedTech innovation. Our client is dedicated to developing and manufacturing life-saving and life-enhancing medical devices that set new standards in patient care. With a culture rooted in scientific excellence and a commitment to quality, they are seeking a visionary and strategic Director of Manufacturing Systems Implementation to join their executive leadership team. This is a pivotal role designed for a leader who can architect and execute a comprehensive digital transformation of the company’s manufacturing landscape.
As the Director, you will be the primary owner of the manufacturing technology roadmap. You will be responsible for the end-to-end strategy, selection, implementation, and optimization of critical manufacturing systems, including Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), Quality Management Systems (QMS), and Laboratory Information Management Systems (LIMS). Reporting directly to the Vice President of Global Operations, you will lead a dedicated team of engineers, project managers, and IT specialists. Your mission will be to build a robust, scalable, and compliant digital manufacturing ecosystem that enhances operational efficiency, ensures unwavering product quality, and supports the company’s aggressive growth trajectory. This position requires a unique blend of deep technical expertise, strategic business acumen, and inspirational leadership, all within the highly regulated environment of the medical device industry.
You will serve as the bridge between the factory floor and the executive suite, translating complex business requirements into tangible technology solutions. Success in this role means not only delivering complex projects on time and within budget but also championing change and fostering a culture of continuous improvement. If you are a transformative leader passionate about leveraging technology to revolutionize manufacturing processes for a company making a real-world impact, we invite you to explore this exceptional opportunity.
Key Responsibilities of Director of Manufacturing Systems Implementation with a MedTech Co. – Irvine, CA
Strategic Roadmap Development
Develop, articulate, and execute a multi-year strategic roadmap for all manufacturing systems, ensuring tight alignment with corporate objectives, product development pipelines, and global operational goals.
Full-Cycle System Implementation
Lead the complete lifecycle of manufacturing system projects, from initial business case development and requirements gathering, through vendor selection, system design, configuration, implementation, validation, and hypercare support.
Program and Project Leadership
Assume ultimate responsibility for the successful delivery of large-scale, cross-functional system implementation programs. Establish rigorous project management frameworks, define key performance indicators (KPIs), manage budgets, and mitigate risks to ensure projects are delivered on schedule and achieve their intended business value.
Regulatory Compliance and Validation
Act as the subject matter expert for system compliance in a regulated environment. Ensure all manufacturing systems and associated processes adhere strictly to FDA regulations (e.g., 21 CFR Part 11, Part 820), ISO 13485, and other relevant international standards. Oversee all computer system validation (CSV) activities, including the development and execution of IQ/OQ/PQ protocols.
Cross-Functional Collaboration
Foster strong, collaborative relationships with key internal stakeholders, including IT, Quality Assurance, Regulatory Affairs, Engineering, Supply Chain, and Finance, to ensure seamless system integration and alignment of processes.
Vendor and Partner Management
Direct the selection and management of software vendors, system integrators, and implementation partners. Negotiate contracts, define statements of work (SOWs), and hold external partners accountable for high-quality deliverables.
Data Integrity and Analytics
Champion the principles of data integrity across all manufacturing platforms. Architect systems to capture high-quality data and leverage analytics to provide actionable insights into manufacturing performance, driving data-driven decision-making and process optimization.
Continuous Improvement and Optimization
Post-implementation, drive a culture of continuous improvement by identifying opportunities to optimize system performance, enhance user adoption, and leverage system capabilities to support Lean Manufacturing and Six Sigma initiatives.
Team Leadership and Development
Recruit, build, and mentor a high-performing team of systems professionals. Provide coaching, set clear performance expectations, and foster a collaborative and innovative team environment.
Requirements for the Director of Manufacturing Systems Implementation with a MedTech Co. – Irvine, CA
Educational Background
A Bachelor’s degree in Engineering (Industrial, Mechanical, or Electrical), Computer Science, Information Systems, or a related technical field is required. A Master’s degree (MS or MBA) is highly preferred.
Professional Experience
A minimum of 12-15 years of progressive experience in manufacturing operations, engineering, or IT, with at least 8 years in a leadership role directly managing large-scale manufacturing system implementations (MES, ERP, QMS).
Industry Expertise
Deep, demonstrable experience within a highly regulated manufacturing industry is mandatory. This includes MedTech, pharmaceuticals, biotechnology, or aerospace. Specific experience in medical device manufacturing is strongly preferred.
Technical Acumen
- Expert-level knowledge of modern MES platforms (e.g., Siemens Camstar, Rockwell Automation PharmaSuite, Werum PAS-X) and ERP systems (e.g., SAP S/4HANA, Oracle NetSuite, QAD).
- Proven expertise in computer system validation (CSV) methodologies, including GAMP 5, and hands-on experience authoring and executing validation protocols (IQ/OQ/PQ).
- Strong understanding of cGMP, ISO 13485, and FDA 21 CFR Part 11 and Part 820 regulations and their application to manufacturing software.
- Familiarity with industrial automation (PLC/SCADA), data integration technologies, and Industry 4.0 concepts.
Leadership and Management Skills
- Demonstrated ability to lead, mentor, and develop a team of technical professionals.
- Exceptional project and program management skills, with a track record of delivering complex, multi-million dollar projects successfully. PMP or similar certification is a plus.
- Superb stakeholder management and communication skills, with the ability to influence and align individuals at all levels of the organization, from shop floor operators to the C-suite.
- Proven change management skills, with experience guiding an organization through the cultural and process shifts associated with major technology implementations.
Strategic and Analytical Mindset
Strong strategic thinking capabilities, with the ability to translate business needs into a coherent technology strategy. Excellent analytical and problem-solving skills are essential.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive benefits package, including:
Competitive Compensation
A lucrative base salary complemented by a significant annual performance-based bonus and a long-term equity/stock option plan.
Comprehensive Health and Wellness
Premium medical, dental, and vision insurance plans for you and your dependents. A robust wellness program, including gym membership reimbursement and mental health resources.
Retirement Planning
A generous 401(k) plan with a strong company match to help you secure your financial future.
Work-Life Balance
A generous paid time off (PTO) policy, paid company holidays, and parental leave programs to support you and your family.
Professional Growth
A dedicated budget for professional development, including funding for certifications (e.g., PMP, Six Sigma), industry conferences, and continuing education.
Innovative Work Environment
The opportunity to work in a state-of-the-art facility in Irvine, CA, with a collaborative, dynamic, and mission-driven team dedicated to improving patient outcomes.
How to Apply
JRG Partners is proud to be the exclusive recruitment partner for this confidential and critical leadership search. We are seeking a visionary leader who is ready to make a significant impact on the future of medical device manufacturing. If your experience and ambitions align with the challenges and opportunities of this role, we strongly encourage you to apply.
To express your interest, please submit your resume and a detailed cover letter outlining your experience with large-scale manufacturing system implementations in a regulated environment. To learn more about our specialized recruitment expertise in this sector, we invite you to visit our Medical Device and Technology Practice Area page. Our dedicated team will review all applications and contact qualified candidates for a confidential discussion.
