NPI Engineer

Actalent; Minnesota; On-site; USD 95,000 - 125,000; Full time

Job summary

Actalent is seeking an New Product Introduction (NPI) Engineer to lead product development from initial quote through process development into full production in a precision machining environment.

You will collaborate with engineering, manufacturing, sales, and customers to ensure robust, scalable processes, develop lean manufacturing SOPs, and maintain BOO/BOM structures in our ERP system. Experience in PFMEA, Gage R&R, and ISO environments is required.

Qualifications

• 4+ years of experience in process development and improvement within a production manufacturing environment, preferably machining.
• Experience with NPI and process engineering for complex machined components.
• Lean manufacturing training or Six Sigma training with practical application.
• Experience in an ISO-regulated environment.
• PFMEA, control plans, and Gage R&R for validation and risk mitigation.

Responsibilities

• Lead product and process development activities from quote to production launch.
• Collaborate with customers to provide manufacturability feedback and influence design for manufacturing.
• Coordinate NPI activities across cross-functional teams including engineering, manufacturing, and sales.
• Develop process variables for machining and secondary operations to ensure repeatable manufacturing outcomes.
• Create and maintain BOO and BOM structures within the ERP system.
• Assist in NPI control plans, PFMEA, qualification activities, and Gage R&R studies.
• Own the first‑run manufacturing process and ensure outputs meet targets.
• Design, document, and improve processes, procedures, and work instructions.
• Create and execute engineering tests to validate processes, tooling, and fixtures.
• Assist in CNC toolpath design and programming methodologies for complex components.
• Design tools, fixtures, and work-holding solutions for precision machining.
• Support costing and quoting with process assumptions and cycle times.
• Drive lean improvements with manufacturing teams.
• Collaborate with sales to align process capabilities with customer needs.
• Coordinate activities between multiple sites for NPI projects and transfers.

Skills

Process development

Machining

NPI

Lean manufacturing

ERP systems

PFMEA/Gage R&R

Fixturing & tooling

ISO environment

CAD software

MS Word/Excel

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Engineering

Associate degree + 5 years experience

Tools

CAM software

CAD software

Job description

Job Description

Job Description

Job Title: New Product Introduction (NPI) Engineer

Job Description

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 throughout the product life cycle to ensure robust, efficient, and scalable processes. The NPI Engineer develops lean manufacturing processes, standard operating procedures, and key process controls to support high-quality, cost-effective production in a precision machining environment.

Responsibilities

• Lead assigned product and process development activities through the early phases of the product life cycle, from quote to production launch.
• Collaborate directly with customers to provide manufacturability feedback and influence design for manufacturing and assembly.
• Coordinate NPI technical activities within the NPI department and across cross‑functional teams, including engineering, manufacturing, and sales.
• Develop key process variables for machining and secondary operations to ensure consistent, repeatable manufacturing outcomes.
• Create and maintain process Bill of Operations (BOO) and Bill of Materials (BOM) structures within the ERP system.
• Assist in the creation of NPI control plans, PFMEA (Process Failure Mode and Effects Analysis), qualification activities, and Gage R&R studies.
• Own the first‑run manufacturing process and ensure key process output variables meet performance, quality, and cost targets.
• Design, document, and continuously improve processes, procedures, and work instructions to support lean and standardized operations.
• Create and execute engineering tests to validate processes, tooling, and fixtures, and to support continuous improvement initiatives.
• Assist in the development of CNC toolpath design and CNC programming methodologies for complex machined components.
• Design tools, fixtures, and part work‑holding solutions for precision machining applications.
• Support all costing and quoting activities by providing process assumptions, cycle times, and manufacturability input.
• Partner with manufacturing teams to drive process improvements, reduce waste, and implement lean manufacturing practices.
• Collaborate with sales and customer‑facing teams to align process capabilities with customer requirements and new business opportunities.
• Coordinate activities between multiple sites as needed to support NPI projects and process transfers.

Essential Skills

• 4+ years of experience in process development and improvement within a production manufacturing environment, preferably machining‑focused.
• Demonstrated experience in production manufacturing (machining), including precision machine shop environments.
• Proven experience in new product introduction (NPI) and process engineering for complex machined or medical device components.
• Hands‑on experience with lean manufacturing principles and continuous improvement methodologies.
• Experience with ERP systems, including creation and maintenance of BOO and BOM structures.
• Practical experience with PFMEA, control plans, and Gage R&R for process validation and risk mitigation.
• Experience in the design and selection of fixturing and tooling for complex parts.
• Experience working within an ISO‑regulated environment.
• Proficiency with CAD software for engineering design and documentation.
• Proficient PC skills in a Windows environment, especially Microsoft Word and Excel.
• Strong written and verbal communication skills, with the ability to clearly document processes and present technical information.
• Strong interpersonal and teamwork skills, with the ability to collaborate across departments and functions.
• Demonstrated ability to coordinate cross‑departmental activities and manage multiple development projects simultaneously.
• Ability to travel between sites as needed to support NPI and process activities.

Additional Skills & Qualifications

• Bachelor’s degree in Engineering, or an associate degree with at least 5 years of experience in a relevant field.
• Experience with CAM software, including Swiss or milling applications, for CNC programming and toolpath development.
• LEAN and/or Six Sigma training with demonstrated practical application in manufacturing environments.
• Experience in medical device or medical technology manufacturing is highly beneficial.
• Experience in manufacturing engineering, production engineering, or process engineering in a precision machining context.
• Experience with sales engineering