Tooling and Equipment Design & Build Manager

Tooling And Equipment Design & Build Manager

Position Summary:

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.

Principal Responsibilities:

• 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.

Education / Experience Requirements:

• 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.

Specialized Skills / Other Requirements:

• 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 technical, operational, and business priorities
• Strong problem-solving and decision-making capabilities
• Knowledge of medical device design controls and regulatory requirements preferred

Working Conditions / Physical Demands:

TRAVEL REQUIRED:

This office/shop hybrid position is based in Wyomissing, PA. Occasional travel to International manufacturing sites and vendors to support equipment selection, procurement, installation and validation may be required. WORKING ENVIRONMENT:
Office/Professional Plant/Manufacturing Remote/Field Laboratory/Shop