New Product Introduction Engineer

About the role

The New Product Introduction (NPI) Engineer manages the transition of new products from development into full-scale production. This role ensures that manufacturing processes, equipment, product designs, and supporting documentation are thoroughly evaluated, optimized, and prepared for successful product launch and ongoing manufacturing.

Responsibilities

• Lead the transition of new products from development into production, ensuring a smooth and controlled introduction into manufacturing.
• Evaluate and refine manufacturing processes, equipment, and product designs to ensure manufacturability, consistency, and scalability.
• Develop, implement, and optimize production processes to support new product launches and ongoing manufacturing operations.
• Plan and execute process development activities, including defining process parameters, workflows, and documentation.
• Drive process improvement initiatives to enhance efficiency, quality, and throughput in a regulated manufacturing environment.
• Coordinate and perform process validation and qualification activities to ensure compliance with applicable standards and regulations.
• Prepare and maintain supporting documentation for manufacturing processes, including work instructions, process specifications, and validation reports.
• Collaborate with Engineering, Quality, Supply Chain, and Operations teams to identify and resolve issues impacting new product introduction and manufacturing transfer.
• Support product launch activities by ensuring production readiness, including equipment, processes, and documentation.
• Facilitate the transfer of products into routine manufacturing by providing training, guidance, and technical support to production teams.

Requirements

• Bachelor’s degree (BS) in Mechanical, Industrial, or a similar engineering discipline.
• 3–5+ years of experience in a regulated manufacturing environment (GMP preferred, ISO or AS9100 experience also considered).
• Hands-on experience in manufacturing engineering and new product introduction.
• Proven experience in process development, including defining, implementing, and optimizing manufacturing processes.
• Demonstrated process improvement experience in a production or regulated environment.
• Experience with process validation and qualification activities.
• Background in product launch or manufacturing transfer, including coordination across cross-functional teams.
• Strong understanding of manufacturability and the ability to design or refine processes for scalable, repeatable production.
• Ability to work effectively with Engineering, Quality, Supply Chain, and Operations teams.

Qualifications

• Additional Skills & Qualifications:
• Experience working under GMP, ISO, or AS9100 quality management systems.
• Exposure to both development and production environments, bridging design and manufacturing.
• Strong documentation skills, including creation and maintenance of process instructions and validation records.
• Continuous improvement mindset with a focus on efficiency, quality, and reliability.
• Excellent communication and collaboration skills for cross-functional team interactions.
• Analytical and problem-solving skills to identify root causes and implement robust process solutions.