Director, New Product Development

Medical Manufacturing Technologies LLC • New Hope, MN

3d

About The Position

MMT is building a new team to develop the next generation of grinding, measurement, and automation equipment used by medical device manufacturers. The Director, New Product Development will build and lead this team in a player-coach role, deciding what to build and participating directly in product specifications, design reviews, prototype work, and development of new machines from concept through first customer shipment. The role also hires and develops the engineering team.

The Director will draw on medical-device-manufacturing experience to ensure new equipment addresses customer process needs and can be validated and used on regulated production lines. The role works with customers and internal teams to identify opportunities, set a product roadmap, manage development programs, and prepare products for launch. The position is based in the Minneapolis–St. Paul area, with work split between onsite, remote, and travel. Travel is approximately 25–40%. The team is expected to grow to about 5–10 engineers.

Requirements

• 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 experience at a medical device OEM, preferred.
• 5+ years leading engineers or cross-functional programs, with direct responsibility for technical results, preferred.
• Track record of taking equipment, process technology, or products from concept to production.
• Practical knowledge of how process equipment is specified, purchased, validated, and operated in an FDA-regulated setting, including 21 CFR 820 QMSR, ISO 13485, and IQ/OQ/PQ.
• Ability to work directly with customers and executives and translate technical detail into a clear business case.
• Ability to work on manufacturing floors and in customer production environments, and occasionally lift up to 25 lbs.

Nice To Haves

• Master’s degree in engineering or an MBA.
• Experience with precision component processes such as grinding, laser processing, coating, wire forming, or catheter manufacturing.
• 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.

Responsibilities

• Engage directly with medical device manufacturers to identify unmet process, throughput, quality, and automation needs.
• Develop product concepts, business cases, and a prioritized roadmap with Sales, Service, and Product Management.
• Assess technical feasibility, cost targets, competing equipment, ROI, IRR, and payback before committing resources.
• Own new machine programs from concept through design, prototyping, build, testing, and launch.
• Write and approve product requirements and specifications, and lead design reviews.
• Provide hands-on technical problem-solving across mechanical, controls, software, and process engineering.
• Run customer trials and process development to demonstrate machine performance on real parts.
• Ensure new machines meet regulated customers’ validation needs, including IQ/OQ/PQ support, documentation, traceability, and data integrity.
• Hire, develop, and lead engineers; determine which skills to build internally and which to obtain from existing engineering groups or partners.
• Establish a lightweight, stage-gated development process that moves quickly while retaining key steps.
• Manage program budgets, schedules, and resources, and report progress to senior leadership.
• Work with Operations to transfer designs for production at the required cost and quality.
• Prepare Sales and Service for launch through specifications, demonstrations, pricing input, training, and early-customer support.
• Manage the full product lifecycle, including tracking launched-product performance and planning end of life for existing platforms as new ones are released.
• Partner with engineering teams at operating sites and support project management on sustaining engineering projects.

Benefits

• Medical, dental, and vision coverage.
• Employer-paid life/AD&D insurance and short- and long-term disability.
• Paid parental leave.
• Ancillary benefits.
• Up to a 4% employer match on 401(k).
• Tuition reimbursement program.
• Scholarship program for dependents, including grandchildren and children under legal guardianship.
• Employee referral bonus program.
• Ongoing development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director