Principal Process Engineer

About This Role

This Principal Process Engineer role supports the Interventional Cardiology & Vascular Therapies (ICVT) team by focusing on Design for Manufacturability, leveraging Contract Manufacturers' capabilities, and developing test strategies for medical device sub-assemblies and consoles. The position requires a Subject Matter Expert to infuse Contract Manufacturing experience into design, integration, NPD, and R&D decisions to improve yields and ramp-up speed at CM sites.

Responsibilities

• Drive and support new product design, testing, integration, and transfer to internal and/or external manufacturing
• Apply technical knowledge to develop innovative processes, procedures, and tooling
• Execute the functional deliverables associated with PDP/TDP and Quality Management Systems
• Provide Design for Manufacturability (DFM) input to the engineering print package
• Prepare and present technical data and recommendations at technical and business reviews
• Ensure quality system compliance for medical device development, champion continuous improvement, and adopt best practices
• Research and evaluate mechanical and electro-mechanical materials, components, assemblies, processes, and/or equipment
• Train and coach technicians and other engineers

Requirements

• Bachelor’s degree in Engineering
• 10+ years of relevant, professional, engineering experience (8+ years with advanced degree)
• Experience working in a highly-regulated industry
• Experience with electro-mechanical device assembly
• Strong cross-functional collaboration and project/task management ability
• Strong written and oral communication skills

Qualifications

• Bachelor’s degree in Engineering
• Minimum of 10 years of relevant, professional, engineering experience; or minimum of 8 years with an advanced degree

Nice to Have

• Bachelor’s degree or higher in Electrical Engineering or Mechanical Engineering
• Previous experience in Medical Capital Equipment manufacturing
• Work experience at PCBA Contract Manufacturer
• Demonstrated knowledge of electronics manufacturing (e.g., Box Build, PCBA test)
• Demonstrated knowledge of engineering fundamentals (LEAN, DFM) and problem-solving tools

Skills

* Required skills