Tooling and Equipment Design & Build Manager

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Expected Travel: Up to 10%

Requisition : 14099

Provide strategic and operational leadership for the design, build, and support of tooling and equipment used in the development and manufacture of disposable medical devices. Lead a multidisciplinary team including toolmaker designers, equipment designers, electrical engineers, and automation/controls technicians. Oversee lab and shop environments while partnering closely with the Machine Shop Manager to deliver integrated, efficient, and high‑quality tooling and equipment solutions.

Define and execute automation strategy to enable scalable, high‑volume production. Lead vendor selection, management, and integration to support equipment development and deployment into production environments.

• Lead and manage a multidisciplinary team responsible for tooling and equipment design, fabrication, assembly, and validation.
• Provide strategic direction for tooling and equipment capabilities aligned to product development and manufacturing needs.
• Oversee design and build of complex tooling, fixtures, and automated equipment systems.
• Ensure integration of mechanical, electrical, controls, vision systems, and safety systems (LOTO, guarding, light curtains, PLC‑based controls).
• Partner with the Machine Shop Manager to align workflows including job intake, prioritization, tracking, and completion.
• Develop and implement systems for job ideation, origination, estimation, tracking, and reporting.
• Coordinate internal and external resources to ensure timely and cost‑effective execution of projects.
• Drive design for manufacturability, reliability, safety, and scalability in all tooling and equipment solutions.
• Oversee lab/shop operations including space utilization, equipment maintenance, safety compliance, and material management.
• Lead troubleshooting and root cause analysis for tooling and equipment issues impacting development or production.
• Review and approve technical documentation including drawings, specifications, validation protocols, and reports.
• Establish and maintain strong partnerships with product design, product engineering, and process development teams.
• Provide technical leadership and guidance on machining processes, machine design, and automation strategies.
• Develop team capabilities through coaching, mentoring, and performance management.
• Manage budgets, capital planning, and resource allocation for tooling and equipment development.
• Interface with vendors and external machine builders to support equipment development and integration.
• Drive continuous improvement initiatives across tooling, equipment, and workflow processes.
• Ensure compliance with quality systems, design controls, EH&S and regulatory requirements.
• Define and drive automation strategy to support transition from development to high‑volume manufacturing.
• Lead vendor selection, qualification, and ongoing management for equipment design, build, and integration.
• Oversee implementation and scaling of automated equipment for high‑volume production, including establishment of machine requirements, factory acceptance, installation, validation, and ramp‑up.
• Champion a culture of safety, accountability, innovation, and company‑first mindset.

• Bachelor’s degree in Engineering or related technical field with 10+ years of relevant experience OR equivalent combination of education and experience.
• Demonstrated experience in tooling, machining, and equipment design/build environments. Proven leadership experience managing technical teams and cross‑functional initiatives.

• Strong background in toolmaking, machining, and machine design
• Proficiency in CAD systems (Solid Works preferred)
• Knowledge of CNC machining, EDM, and fabrication processes
• Understanding of automation systems, PLCs, sensors, and controls integration
• Knowledge of safety systems including lockout/tagout, guarding, and light curtains
• Strong leadership, communication, and team development skills
• Experience with job tracking systems, ERP/MES tools, or similar workflows
• Ability to balance…