New Product Introduction (NPI) Manager

Engenious Design•Prairie Village, KS

2d•Onsite

About The Position

The NPI Manager oversees all aspects of in-house prototype and manufacturing builds for medical devices and other technology systems. This role works alongside design engineers from early design reviews through pilot production at Engenious and design transfer to contract manufacturers. The scope of work includes planning and building components, subassemblies, fixtures, prototypes, pilot production runs, and finished device production (short run). Builds require leading and directly managing the day-to-day activities of highly skilled teams in a safe, organized and controlled environment. This individual manages both processes and personnel. The NPI team reviews designs early for manufacturability and assembly, feeding that input back to design engineers before a design locks, then leads the transfer of the finished design into a new manufacturing setup at contract manufacturers. They manage inventory, tools, equipment and people for on-schedule, within-budget execution of all NPI group work, and maintain and improve business and quality system processes that meet FDA and ISO standards. The manager coordinates with clients, suppliers, and engineering at a leadership level, establishes supplier quality agreements, and maintains the safety of all who work in the production areas. This is a full-time position in the Kansas City metro. Potential growth path to director, general manager and beyond.

Requirements

Minimum 3 years of experience directly managing a team in an NPI, prototype, or manufacturing environment, ideally for medical devices or another regulated industry.
Minimum 2 years of experience leading design transfer to contract manufacturers, including standing up new manufacturing processes and production lines.
Experience partnering with design engineers on manufacturability, tolerancing and assembly feedback during product development.
Minimum 2 years of experience estimating and managing project work to schedule and budget.
Experience managing supplier relationships, including supplier quality agreements and corrective actions.
Degree in a relevant engineering background (e.g Manufacturing, Biomedical, Mechanical, Electrical, Software), or equivalent experience.

Nice To Haves

Experience with lean process (Toyota Production System) or equivalent continuous improvement methods.
Background in mechanical, manufacturing or electrical engineering, or equivalent hands-on experience.
Working knowledge of FDA and ISO quality system requirements, including design controls and audit readiness.
Experience with electro-mechanical or electronics assembly for medical devices.

Responsibilities

Leading the design-to-production handoff for medical devices and other technology systems, from hands-on prototype builds through new manufacturing setup at contract manufacturers.
Establishing production forecasts and managing materials.
Making and qualifying plastic tooling.
Creating manufacturing plans.
Establishing production and test process.
Qualifying equipment and validating production processes.
Overseeing all aspects of in-house prototype and manufacturing builds for medical devices and other technology systems.
Working alongside design engineers from early design reviews through pilot production at Engenious and design transfer to contract manufacturers.
Planning and building components, subassemblies, fixtures, prototypes, pilot production runs, and finished device production (short run).
Leading and directly managing the day-to-day activities of highly skilled teams in a safe, organized and controlled environment.
Managing both processes and personnel.
Reviewing designs early for manufacturability and assembly, feeding that input back to design engineers before a design locks.
Leading the transfer of the finished design into a new manufacturing setup at contract manufacturers.
Managing inventory, tools, equipment and people for on-schedule, within-budget execution of all NPI group work.
Maintaining and improving business and quality system processes that meet FDA and ISO standards.
Coordinating with clients, suppliers, and engineering at a leadership level.
Establishing supplier quality agreements.
Maintaining the safety of all who work in the production areas.