The Senior Operations Manufacturing Site Leader - Colorado Springs in the medical devices industry is directly responsible for the service, cost, quality, and safety performance of the manufacturing site(s) under their leadership, the successful production launch of products in the NPI (new product introduction) pipeline, site culture development, and the execution of strategic initiatives in line with the performance and future growth of the site. More specifically, the Senior Operations Manufacturing Site Leader - Colorado Springs is responsible for: Operational Leadership: Ensure successful end-to-end site operations, best practices implementation, digitalization, and strategic engineering programs to achieve growth, scale, and cost objectives in line with the commercial strategy; Ensure quality and regulatory compliance, oversee the operational excellence and engineering roadmap for the site, lead and coordinate all cross-functional teams to deliver high-quality products efficiently and safely. Lead cross-functional teams and partnerships including but not limited to third party sterilization, quality, procurement, supplier quality, facilities, R&D, human resources, IT, Distribution, demand and supply planning, finance, and others in order to ensure the successful operational performance of the site. Strategic Planning: Develop and implement strategic operational plans, applying advanced KPIs and best practices to improve productivity, reduce costs, optimize efficiency, and scale manufacturing capabilities. Quality & Regulatory Compliance: Ensure full compliance with regulatory and quality standards such as FDA QSR, ISO 13485, and EU MDR. Maintain oversight of the site quality organization, cost of quality, defect resolution, and process performance metrics. Operational Excellence: Develop and guide the strategy for Lean Manufacturing, Six Sigma, continuous improvement, and other operational excellence initiatives. Guide and direct the roadmap for the Operational Excellence team, including process optimization, equipment modernization, and automation implementation. Resiliency Roadmap: Develop and implement, in partnership with Engineering, Sterilization, R&D, Supply Chain, and Quality teams, a roadmap to support long-range capacity planning, new product introductions, production scaling, and supply chain resilience. Team Development: Mentor, coach, and develop high-performing production, engineering, and leadership teams. Foster a culture of continuous improvement, accountability, and engagement. Financial Management: Develop and manage manufacturing budgets, oversee cost control, resource allocation, and capital project investments. External Representation: Represent the company at industry events and within partnerships or supplier networks, enhancing brand reputation and operational collaboration. Key jobs to be done: Optimize the end-to-end performance of two key value streams for lasers and catheters, integrating raw materials management, material handling, production scheduling, manufacturing, and third-party sterilization to improve the predictability and throughput of the value chain. Lead the cultural transformation of a shared site, driving to a “one team” mentality across Advanced Manufacturing Engineering (AME), R&D, Quality, Planning, and Production at the facility. Design the long-term strategic roadmap for the site, including space utilization, capital investment, value stream systems digitalization, and automation technology. Develop and build critical skills across the end-to-end value stream team, including Lean Manufacturing, Six Sigma, Kaizen, First-Time-Right quality, financial acumen, and value stream model implementation.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Job Type
Full-time
Career Level
Senior