NPI Engineer: Launch & Scale New Products

6AM City, LLC; False Pass (AK); On-site; USD 95,000 - 105,000; Full time

Job summary

6AM City, LLC in Southampton, PA is seeking a New Product Introduction Engineer to manage the transition of new products from development into full-scale production. This role ensures that manufacturing processes, equipment, product designs, and documentation are evaluated, optimized, and prepared for successful product launch and ongoing manufacturing.

You will collaborate with cross-functional teams in Engineering, Quality, Supply Chain, and Operations to develop scalable, repeatable

Qualifications

• 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.

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.

Skills

Manufacturing engineering

New product introduction

Process development

Process validation

Cross-functional collaboration

Education

BS in Mechanical/Industrial engineering

Job description

6AM City, LLC in Southampton, PA is seeking a New Product Introduction Engineer to manage the transition of new products from development into full-scale production. This role ensures that manufacturing processes, equipment, product designs, and documentation are evaluated, optimized, and prepared for successful product launch and ongoing manufacturing.

You will collaborate with cross-functional teams in Engineering, Quality, Supply Chain, and Operations to develop scalable, repeatable