Overview

ABOUT THE ROLEMMT designs and builds the grinding, measurement, and automation equipment that medical device manufacturers rely on to make guidewires, catheters, implants, and other precision components. Our machines run on their production floors every day.We're building a new team to create the next generation of that equipment, and we're looking for a Director, New Product Development to build and lead it from the ground up. This is a player-coach role. You'll decide what we build, write and review specifications, run design reviews, work through prototypes, and take new machines from concept to first customer shipment. You'll also hire and develop the team that does this work with you.The ideal candidate has spent their career inside a medical device manufacturer. You know from the customer side what process equipment has to do, how it gets validated, and why a machine succeeds or fails on a regulated production line. We want that insight built into every product we make.WHAT YOU'LL DOTalk directly with medical device manufacturers to find unmet process, throughput, quality, and automation needsTurn those needs into product concepts, business cases, and a prioritized roadmap, working with Sales, Service, and Product ManagementAssess technical feasibility, cost targets, competing equipment, and ROI, IRR, and payback before committing resourcesOwn new machine programs from concept through design, prototype, build, test, and launchWrite and approve product requirements and specifications, and lead design reviewsGet hands-on with technical problem-solving across mechanical, controls, software, and process engineeringRun customer trials and process development to prove machine performance on real partsMake sure new machines meet the validation needs of regulated customers, including IQ/OQ/PQ support, documentation, traceability, and data integrityHire, develop, and lead a team of engineers, and decide which skills to build in-house and which to borrow from existing engineering groups or partnersSet up a lightweight, stage-gated development process that moves quickly without skipping key stepsManage program budgets, schedules, and resources, and report progress to senior leadershipWork with Operations to hand off designs that can be built at the right cost and qualityPrepare Sales and Service for launch with specifications, demos, pricing input, training, and early-customer supportManage the full product lifecycle, from tracking how launched products perform to planning end of life for existing platforms as new ones are releasedPartner with engineering teams at our operating sites, and support project management on sustaining engineering projectsWHAT SUCCESS LOOKS LIKE IN YOUR FIRST YEAR90 days: You've met key customers and internal teams, and presented a first set of product opportunities with business cases.6 months: Your roadmap is approved, your first program is past concept review, and your core hires are in place.12 months: Your first new machine is at a working prototype or in customer trials, and a development process is in place and in use.WHAT YOU'LL BRINGBachelor's degree in Mechanical, Biomedical, Manufacturing, or Electrical Engineering, or a closely related field, preferred; an equivalent combination of education and experience will be considered12+ years in medical device manufacturing or development, including significant time at a medical device OEM, preferred5+ years leading engineers or cross-functional programs, with direct responsibility for technical results, preferredA track record of taking equipment, process technology, or products from concept to productionPractical knowledge of how process equipment is specified, purchased, validated, and run in an FDA-regulated setting (21 CFR 820 QMSR / ISO 13485, IQ/OQ/PQ)Comfort working directly with customers and executives, and turning technical detail into a clear business caseNice to have:Master's degree in engineering or an MBAExperience with precision compone