NPI Engineer

New Product Introduction (NPI) Engineer

The New Product Introduction (NPI) Engineer leads products from initial quote through process development and into full production manufacturing. This role collaborates closely with engineering, manufacturing, sales, and customer teams to develop robust, lean, and scalable processes. The NPI Engineer plays a key role in improving product designs for manufacturability, establishing standard operating procedures, and ensuring successful first-run production in a precision machining environment that supports medical device and medical technology customers.

Responsibilities

• Lead assigned product and process development activities through the early phases of the product life cycle, from quote to production manufacturing.
• Collaborate directly with customers to provide feedback on manufacturability and recommend design and process improvements.
• Coordinate NPI technical functions within the NPI department and across cross-functional teams, including engineering, manufacturing, and sales.
• Develop key process variables for machining operations and secondary processes to ensure consistent and repeatable manufacturing outcomes.
• Create and maintain process Bills of Operations (BOO) and Bills of Materials (BOM) structures within the ERP system.
• Assist in the creation and maintenance of NPI control plans, PFMEA (Process Failure Mode and Effects Analysis), qualification plans, and GR&R (Gage Repeatability and Reproducibility) activities.
• Own the first-run manufacturing process and ensure that key process output variables meet performance, quality, and cost targets.
• Design, document, and continuously improve developed processes, procedures, and work instructions to support standardized operations.
• Create and execute engineering tests to validate processes, tooling, and equipment performance.
• Assist in the development of CNC toolpath design and CNC programming methodology for Swiss and milling operations.
• Design tools, fixtures, and work-holding solutions for complex precision-machined parts.
• Support costing and quoting activities by providing process, tooling, and cycle time inputs.
• Drive process development and continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Collaborate with sales engineering and customer-facing teams to support technical discussions and customer relations.
• Work within ISO-compliant quality systems and documentation requirements to support medical device and precision manufacturing standards.
• Coordinate activities across departments and multiple sites, including occasional travel as needed to support NPI projects.

Essential Skills

• 4+ years of experience in process development and improvement within a production manufacturing environment, preferably machining-focused.
• Proven experience in production manufacturing (machining) with a strong understanding of manufacturing processes for precision components.
• Hands-on experience with CNC machining and related operations, including familiarity with Swiss or milling processes.
• Demonstrated expertise in Lean Manufacturing, process improvement, and continuous improvement methodologies.
• Experience with New Product Introduction (NPI) in a manufacturing or medical device environment.
• Proficiency in developing and managing manufacturing processes, including routing, work instructions, and standard operating procedures.
• Experience working within an ISO-regulated environment, preferably in medical device or related industries.
• Strong knowledge of manufacturing process engineering, including PFMEA, control plans, and GR&R studies.
• Experience with ERP systems, including creation and maintenance of BOO and BOM structures.
• Proficiency with CAD software for reviewing and supporting design and manufacturability.
• Proficient PC skills in a Windows environment, especially Microsoft Word and Excel.
• Effective written and verbal communication skills with the ability to clearly convey technical concepts to cross-functional teams and customers.
• Strong interpersonal and teamwork skills with the ability to collaborate across departments.
• Demonstrated ability to manage multiple development activities simultaneously and prioritize tasks effectively.
• Experience in the design and selection of fixturing and tooling for complex, precision-machined parts.
• Experience working in a precision machine shop environment with high quality and tight tolerance requirements.
• LEAN and/or Six Sigma training with demonstrated application in a production environment.
• Ability to travel between sites as needed to support NPI projects and cross-site coordination.

Additional Skills & Qualifications

• Bachelor's degree in Engineering, or an associate degree with at least 5 years of experience in an applicable field.
• Background in medical device, medical technology, or similarly regulated industries.
• Experience with CAM software for CNC programming, including Swiss and milling operations.
• Exposure to sales engineering or customer-facing technical roles, supporting quoting and…