NPI Process Engineer I

About the position

The NPI Process Engineer will work directly with Engineering and Manufacturing managing various projects geared toward designing efficiency, cost effectiveness and safety controls within our manufacturing and engineering processes.

Responsibilities

• Plan, execute, and direct validation activities for both NPI and existing product lines.
• Maintain and create documentation including validation protocols, SOPs, test plans, test reports, PFMEA, VMP, quality and validation reports, technical proposals and more.
• Perform RCA (Root Cause Analysis) and resolve design or manufacturing issues.
• Support Engineering teams on reviewing, designing, prototyping, and testing.
• Support and coordinate with internal and external Engineering teams to create solutions, meet deadlines, and provide customer satisfaction throughout the product life cycle.
• Manage engineering projects of varying size and complexity.

Requirements

• Bachelor's degree in Engineering or similar technical programs.
• Prior experience with catheter manufacturing process development is a plus.
• Understanding of product validation, manufacturing processes, and development of electrical and mechanical devices.
• Experience in performance of new technology research, creation of product documentation, product testing protocols, and test reporting is a plus.
• Background in design for manufacture, quality processes, and documentation of highly regulated (medical or similar) products is a plus.
• Understanding of manufacturing methods related to catheter fabrication.
• Experience working with extrusion, braiding, lamination, and secondary operations.
• Strong writing skills creating documentation as mandated by ISO 13485, FDA, or similar regulations.

Nice-to-haves

• Experience with design/production of medical devices under ISO 13485.

Benefits

• Competitive salary and bonus compensation.
• Medical, Dental, Vision, and HSA plans.
• Life, AD&D, STD, LTD plans to help protect you and your loved ones.
• Generous 401k plan with 5% Employer Match.
• Paid Holidays, PTO, and other leave programs to support your time off needs.
• Learning & Development Program.