Director, New Product Development in New Hope, Minnesota at Medical Manufacturing Technologies LLC

ABOUT THE ROLE

MMT 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 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.
• 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 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. Paul, MN area, with time split between on site, remote, and travel
• Reports to: President, MMT
• Team: Starts as an individual contributor or with a small team, growing to about 5 to 10 engineers
• Travel: About 25 to 40%, to customer sites, MMT manufacturing locations, and trade shows
• Physical requirements: Time on manufacturing floors and in customer production environments, and the ability to occasionally lift up to 25 lbs

BENEFITS

We offer full benefits, including medical, dental, and vision coverage, employer-paid life/AD&D and short- and long-term disability, paid parental leave, plus a range of ancillary benefits. You'll also get up to a 4% employer match on your 401(k), a tuition reimbursement program, a scholarship program for dependents (including grandchildren and children under legal guardianship), an employee referral bonus program, and ongoing development opportunities.

Reasonable accommodations will be made to enable qualified individuals with disabilities to perform the essential functions of this role. If you require an accommodation during the application or interview process, please contact Human Resources.

Medical Manufacturing Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive workplace and consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, sexual orientation, gender identity or expression, marital status, medical condition, ancestry, citizenship, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.

MMT participates in E-Verify. In accordance with federal law, upon hire all employees will be required to provide documentation establishing their identity and authorization to work in the United States.