New Product Introduction (NPI) Manager

Engenious Design•Prairie Village, KS

92d

About The Position

Engenious Design is hiring a hands-on NPI Manager to lead design-to-production handoffs for medical devices and other technology systems. The role oversees in-house prototype and manufacturing builds, working alongside design engineers from early design reviews through pilot production at Engenious and design transfer to contract manufacturers. Work includes planning and building components, subassemblies, fixtures, prototypes, pilot production runs, and finished devices in short runs. The manager leads and directly manages skilled teams and is responsible for both processes and personnel in a safe, organized, and controlled environment. The NPI team provides early manufacturability and assembly feedback to design engineers, then transfers finished designs into new manufacturing setups at contract manufacturers. The manager oversees inventory, tools, equipment, and personnel to deliver NPI work on schedule and within budget; maintains and improves business and quality-system processes to meet FDA and ISO standards; coordinates at a leadership level with clients, suppliers, and engineering; establishes supplier quality agreements; and maintains production-area safety. The work ranges from production forecasting and materials management to making and qualifying plastic tooling, creating manufacturing plans, establishing production and test processes, qualifying equipment, and validating production processes. This is a full-time position in the Kansas City metro area. The posting notes a potential growth path to director, general manager, and beyond.

Requirements

At least 3 years of experience directly managing a team in an NPI, prototype, or manufacturing environment, ideally in medical devices or another regulated industry.
At least 2 years of experience leading design transfer to contract manufacturers, including establishing new manufacturing processes and production lines.
Experience partnering with design engineers on manufacturability, tolerancing, and assembly feedback during product development.
At least 2 years of experience estimating and managing project work to schedule and budget.
Experience managing supplier relationships, including supplier quality agreements and corrective actions.
A degree in a relevant engineering field, such as manufacturing, biomedical, mechanical, electrical, or software engineering, or equivalent experience.

Nice To Haves

Experience with lean processes, such as the Toyota Production System, or equivalent continuous-improvement methods.
A 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 electromechanical or electronics assembly for medical devices.

Responsibilities

Oversee in-house prototype and manufacturing builds for medical devices and other technology systems.
Lead design-to-production handoffs, from early design reviews through pilot production and transfer to contract manufacturers.
Plan and build components, subassemblies, fixtures, prototypes, pilot production runs, and finished-device short runs.
Lead and directly manage the day-to-day work of skilled teams in a safe, organized, and controlled environment.
Partner with design engineers to provide early feedback on manufacturability and assembly.
Manage inventory, tools, equipment, and personnel to execute NPI work on schedule and within budget.
Establish production forecasts and manage materials.
Make and qualify plastic tooling; create manufacturing plans; establish production and test processes; qualify equipment; and validate production processes.
Maintain and improve business and quality-system processes that meet FDA and ISO standards.
Coordinate with clients, suppliers, and engineering at a leadership level.
Establish supplier quality agreements and manage supplier relationships and corrective actions.
Maintain the safety of people working in production areas.