WHAT YOU'LL DO Talk directly with medical device manufacturers to find unmet process, throughput, quality, and automation needs Turn those needs into product concepts, business cases, and a prioritized roadmap, working with Sales, Service, and Product Management Assess technical feasibility, cost targets, competing equipment, and ROI, IRR, and payback before committing resources Own new machine programs from concept through design, prototype, build, test, and launch Write and approve product requirements and specifications, and lead design reviews Get hands-on with technical problem-solving across mechanical, controls, software, and process engineering Run customer trials and process development to prove machine performance on real parts Make sure new machines meet the validation needs of regulated customers, including IQ/OQ/PQ support, documentation, traceability, and data integrity Hire, develop, and lead a team of engineers, and decide which skills to build in-house and which to borrow from existing engineering groups or partners Set up a lightweight, stage-gated development process that moves quickly without skipping key steps Manage program budgets, schedules, and resources, and report progress to senior leadership Work with Operations to hand off designs that can be built at the right cost and quality Prepare Sales and Service for launch with specifications, demos, pricing input, training, and early-customer support Manage the full product lifecycle, from tracking how launched products perform to planning end of life for existing platforms as new ones are released Partner with engineering teams at our operating sites, and support project management on sustaining engineering projects WHAT SUCCESS LOOKS LIKE IN YOUR FIRST YEAR 90 days: You've met key customers and internal teams, and presented a first set of product opportunities with business cases. WHAT YOU'LL BRING Bachelor's degree in Mechanical, Biomedical, Manufacturing, or Electrical Engineering, or a closely related field, preferred; an equivalent combination of education and experience will be considered 12 years in medical device manufacturing or development, including significant time at a medical device OEM, preferred 5 years leading engineers or cross-functional programs, with direct responsibility for technical results, preferred A track record of taking equipment, process technology, or products from concept to production Practical 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 case Nice to have: Master's degree in engineering or an MBA Experience with precision component processes such as grinding, laser processing, coating, wire forming, or catheter manufacturing A background in manufacturing engineering, advanced manufacturing, or equipment development within an OEM Experience at a capital equipment supplier, or in buying and qualifying capital equipment Familiarity with automation, machine vision, in-line metrology, and Industry 4.0 data capture Experience building a new team or function from scratch ROLE DETAILS Location: Minneapolis–St.