Sr NPI Manufacturing Engineer

Job Overview

This highly skilled manufacturing engineer will support flexible instruments and accessories for the Ion platform. The engineer will develop new and improved manufacturing processes by collaborating across functions to solve a wide variety of technical process and equipment problems. They will have demonstrated experience developing and improving flexible instruments and/or catheter manufacturing processes such as lamination, thermal bonding, injection molding, and UV‑cured adhesives.

• Contribute to the development of new manufacturing processes:
  • Experience in early development of flexible instrument manufacturing processes, including process tradeoff assessments
  • Experience working with a wide range of plastic and metal joining processes, such as laser welding, adhesive bonding, lamination/plastic reflow, injection molding
  • Comfortable with experiment design (DOE) to identify and control critical process parameters – demonstrated successful transfer of complex manual processes to high volume, high capability
  • Experience developing flexible instrument/catheter manufacturing lines – establishing order of operations, building and testing prototypes, training operators, defining fixture/tooling requirements, and conducting process validation
  • Maintains connections with leading catheter manufacturing equipment suppliers and is aware of latest state‑of‑the‑art processes and equipment
  • Proven track record of working upstream with product design engineers and can be the voice of manufacturing on product development teams
• Support Ion manufacturing lines including:
  • Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
  • Manage product reliability improvements from concept to implementation
  • Identify, design, qualify, document and introduce assembly/test fixtures and equipment
  • Improve process flows of Ion instrument manufacturing lines to optimize for manufacturability – e.g. reliability, efficiency, capacity, and safety
  • Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
  • Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
  • Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
  • Provide technical support for failure analyses and root cause investigations of product failures
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress
• Provide resource budget estimates for product and process improvements, tooling development, and testing
• Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements

• Strong technical analytical skills and troubleshooting skills
• Prior responsibility for validation/verification of processes, equipment and products
• Strong organizational skills and proven ability to work on several fast‑paced projects simultaneously
• Prior experience with managing product and process changes
• Prior experience with technical writing
• Able to communicate effectively and professionally with cross‑functional peers, executive leadership, internal customers and external suppliers

• Minimum BS degree in Engineering discipline, MS preferred
• Minimum 8 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro‑optical content
• Prior responsibility for validation/verification of processes, equipment and products

• Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma Black/Green Belt is a plus
• Prior experience with Design Control processes for medical devices and/or clinical applications of…