About The Position

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.

Requirements

  • Bachelor’s degree in engineering or a related technical discipline; Advanced degree preferred.
  • Minimum 20 years of relevant experience in complex manufacturing and engineering environments with demonstrated leadership in operational and technical team management.
  • Experience with new product introduction (NPI), production scaling, process optimization, and facility upgrades.
  • Lean Manufacturing, Six Sigma, or equivalent certification.
  • Demonstrated experience leading, coaching, and developing teams to deliver operational efficiency improvements, scaling operations, change management, with strong culture and engagement results.
  • Proven ability to lead large teams, influence without direct authority, and manage cross-functional, geographically diverse teams.
  • Deep understanding of manufacturing processes, Lean methodology, automation technologies, and quality improvement tools such as SPC, DOE, PFMEA.
  • Strong problem-solving, decision-making, and data-driven operational analysis capabilities.
  • Experience in regulated environments, including FDA, ISO, compliance audits, and risk management.
  • Excellent executive presence, interpersonal, negotiation, and presentation skills to interface with internal teams, executives, suppliers, and external partners.
  • Ability to manage multiple priorities, dynamic production environments, and rapidly evolving projects and technologies.
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

  • Advanced degree preferred.

Responsibilities

  • 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.
  • Develop and implement strategic operational plans, applying advanced KPIs and best practices to improve productivity, reduce costs, optimize efficiency, and scale manufacturing capabilities.
  • 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.
  • 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.
  • 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.
  • Mentor, coach, and develop high-performing production, engineering, and leadership teams.
  • Foster a culture of continuous improvement, accountability, and engagement.
  • Develop and manage manufacturing budgets, oversee cost control, resource allocation, and capital project investments.
  • Represent the company at industry events and within partnerships or supplier networks, enhancing brand reputation and operational collaboration.
  • 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.

Benefits

  • generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • stock purchase plan
  • education reimbursement
© 2026 Teal Labs, Inc
Privacy PolicyTerms of Service