Senior Manager, Metals Process Engineering

Responsibilities

• Manage and develop a multidisciplinary team of engineers and technicians.
• Build technical depth, drive engagement, and maintain a strong culture of safety and compliance.
• Oversee day-to-day pilot manufacturing operations including scheduling, priority setting, capacity planning, and resource allocation to support multiple internal customers across R&D, new product introduction, and early commercial production.
• Sustain and manage metals manufacturing technologies, ensuring robust process capability, optimal tool selection, machine performance, and alignment with long-term manufacturing strategies.
• Lead the integration, validation, and scale-up of metals processing technologies with a global manufacturing footprint as the downstream transfer recipient.
• Drive automation and lights-out manufacturing, including robotic load/unload, chemical monitoring, in-process inspection, and machine connectivity to enhance productivity and consistency.
• Partner with Engineering, IT/MES, and equipment suppliers to support Industry 4.0 initiatives, including data-driven machining, machine health monitoring, and digital work instructions.
• Ensure accurate maintenance documentation, spare parts management, and equipment performance monitoring to maximize uptime and OEE.
• Collaborate with Manufacturing Engineering, Quality, Supply Chain, the metals Center of Excellence and R&D on machining-related strategies, budgets, equipment planning, and process validation (IQ/OQ/PQ).
• Support new product development by coordinating prototype machining, providing DFM/A input, and preparing machining processes for scalable production transfer.
• Successfully launch, stabilize, and transfer novel manufacturing processes to the Metals commercial manufacturing network.
• Manage metals NPD projects with full accountability for schedule, scope, risk management, and quality outcomes.
• Ensure all manufacturing processes comply with ISO 13485, FDA QSR, and environmental, health, and safety requirements.
• Maintain documentation, calibration systems, process controls, and traceability appropriate for regulated medical device manufacturing.
• Drive process optimization through SPC, root cause investigation, standard work, and lean/Six Sigma methodologies and alignment to Edwards Production System (EPS).
• Deploy metrics and dashboards that clearly communicate shop performance, capacity utilization, and improvement opportunities.
• Support the New Product Introduction and R&D teams in the optimal technology selection and early process development for new products.
• Negotiate priorities across stakeholders, resolve conflicts, and ensure high satisfaction with machining services.

Requirements

• Bachelor's degree in Engineering.
• Demonstrated experience leading medical device manufacturing and/or NPD teams.

Preferred

• 8+ years of experience in medical device manufacturing/NPD.
• Strong technical knowledge of complex equipment, automation, process controls/validation, metrology, and tooling.
• Experience with Nitinol component/stent manufacturing processes.
• MBA or other advanced degree.
• Experience with injection molding and/or extrusion manufacturing processes.
• Proven experience implementing automation, robotics, or lights-out manufacturing.
• Experience with commercial transfer and scale up.
• Proven experience deploying or managing TPM, preventive maintenance programs, or equipment reliability strategies.
• Strong project management and capital equipment planning skills.
• Proficiency with ERP/MES systems, CAM/CAD tools, and machining data systems.
• Excellent interpersonal, communication, and stakeholder management skills.
• Financial acumen related to tooling assets, equipment cost management, and capital investments.
• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Ability to thrive in a high-mix, fast-changing production environment.
• Ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.