Senior Manager, Metals Process Engineering

Innovation starts from the heart. Edwards Lifesciencesis the leading global structural heart innovation company driven by a passion to improve patient lives.With millions of patients served in over 100 countries each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.

As part of our Metals organization you will lead the people processes and technologies that produce high-accuracy high-reliability components for implant and delivery systems. Your leadership in advanced metals processing automation and continuous improvement will translate innovation into world-class manufacturing performance.

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 youll 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 youll need (Required):

• Bachelors degree in Engineering
• Demonstrated experience leading medical device manufacturing and/or NPD teams

What else youll 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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.