This Senior Manager will oversee a high-performance team responsible for delivering high-precision metal implant components using state-of-the-art laser cutting, heat treatment, electropolishing, and automated inspection systems. This leader ensures operational excellence, technology readiness, capacity planning, and compliance with medical device quality and safety requirements while serving multiple new product development and commercial manufacturing teams. Responsibilities include the development and sustaining of the metals nitinol portfolio & technology roadmap, leading and supporting manufacturing automation initiatives, and implementing technical knowledge sharing programs across the global metals manufacturing network.
How you'll make an impact:- 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.
What you'll need (Required):- Bachelor's degree in Engineering
- Demonstrated experience leading medical device manufacturing and/or NPD teams
What else you'll need (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
- 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
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
