The Role
Hands-on manager overseeing prototype model shop and short-run production for medical devices and other electro-mechanical systems. Leads NPI from design review through pilot production and design transfer, manages people, suppliers, inventory, tools and quality processes to meet FDA/ISO standards, and coordinates with clients and engineering for on-schedule, within-budget execution.
Summary Generated by Built In
NPI ManagerAre you interested in both device design and manufacturing? Easily bored by the repetitive, but excited by unique challenges? Our NPI team is a collection of prototype specialists, manufacturing engineers, technicians, material managers and others who understand medical device production controls.
We have an opportunity for a full-time position in the Kansas City metro, 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. Potential growth path to director, general manager and beyond.
From establishing production forecasts and managing materials, to making and qualifying plastic tooling. Creating manufacturing plans, establishing production and test process, qualifying equipment and validating production processes along the way. NPI is a lot of work, and our NPI team does anything it takes to get clients to market, with so much more urgency than a standard contract manufacturer.
Company overviewFounded in 2013, Engenious Design is a growing team of 90+ people who design, prototype, build and test medical devices and other high technology systems for our clients. We don’t make or sell anything with our name on it, but we work on behalf of our customers who market and sell the systems we design. We are a blend of Creative Design mixed with Engineering - Industrial Designers, Graphic Designers, Mechanical/Electrical/Embedded Software Engineers. We design, prototype and test electro-mechanical systems in a collaborative team that’s based in the Kansas City metro area.
Our prototype model shop and short-run production areas are well-outfitted, clean, organized and air-conditioned. Our model shop creates photo-worthy appearance models (like movie props) and functional prototypes to support R&D work that makes the world better through the systems we design. Our production team produces limited quantity, high-quality final assembly and test of medical devices and other technology systems in an electronics lab environment.
Position summaryThe hands-on NPI Manager oversees 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. 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.
Required skills to have for the success of this role
We have an opportunity for a full-time position in the Kansas City metro, 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. Potential growth path to director, general manager and beyond.
From establishing production forecasts and managing materials, to making and qualifying plastic tooling. Creating manufacturing plans, establishing production and test process, qualifying equipment and validating production processes along the way. NPI is a lot of work, and our NPI team does anything it takes to get clients to market, with so much more urgency than a standard contract manufacturer.
Company overviewFounded in 2013, Engenious Design is a growing team of 90+ people who design, prototype, build and test medical devices and other high technology systems for our clients. We don’t make or sell anything with our name on it, but we work on behalf of our customers who market and sell the systems we design. We are a blend of Creative Design mixed with Engineering - Industrial Designers, Graphic Designers, Mechanical/Electrical/Embedded Software Engineers. We design, prototype and test electro-mechanical systems in a collaborative team that’s based in the Kansas City metro area.
Our prototype model shop and short-run production areas are well-outfitted, clean, organized and air-conditioned. Our model shop creates photo-worthy appearance models (like movie props) and functional prototypes to support R&D work that makes the world better through the systems we design. Our production team produces limited quantity, high-quality final assembly and test of medical devices and other technology systems in an electronics lab environment.
Position summaryThe hands-on NPI Manager oversees 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. 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.
Required skills to have for the success of this role
- 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.
- Must have 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 equivalant experience.
- 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.
Skills Required
- Minimum 3 years managing a team in NPI, prototype, or manufacturing environments (preferably medical device or regulated industry).
- Minimum 2 years 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.
- Minimum 2 years 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 discipline (Manufacturing, Biomedical, Mechanical, Electrical, Software) or equivalent experience.
- Working knowledge of FDA and ISO quality system requirements, including design controls and audit readiness.
- Experience with lean processes (Toyota Production System) or continuous improvement methods.
- Background or hands-on experience with mechanical, manufacturing, or electrical engineering and electro-mechanical or electronics assembly for medical devices.
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The Company
What We Do
Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty. We fold into client development teams, working alongside as design partners. Our uniquely-integrated approach means lower-risk development and more transparency. Our team’s portfolio includes FDA Class II, III and PMA devices. We plan, specify, architect, design, prototype, verify, validate and transfer devices to production. Our focus is on electronic, mechanical and embedded software medical devices. Because of our medical device focus, we have an ISO:13485 / 21CFR820 - compliant quality system.
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