Senior Manager, Metals Process Engineering

Overview

As part of Edwards Lifesciences Metals organization, you will lead people, processes, and technologies that produce high‑accuracy, high‑reliability metal implant components for implant and delivery systems.

• Lead a multidisciplinary team of engineers and technicians, fostering technical depth, safety culture, and compliance.
• Oversee day‑to‑day pilot manufacturing operations, including scheduling, priority setting, capacity planning, and resource allocation to support R&D, new product introduction, and early commercial production customers.
• 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 within 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 such as 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 aligned 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 optimal technology selection and early process development for new products.
• Negotiate priorities across stakeholders, resolve conflicts, and ensure high satisfaction with machining services.

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

• 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 and partnering with HR on all aspects of employee relations.
• Adherence to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and adequate control measures to prevent injuries and environmental harm.

• Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
• COVID‑19 vaccination is required for all patient‑facing and in‑hospital positions unless a medical or religious exemption is approved.