Director, Medical Device NPD & Innovation

Medical Manufacturing Technologies; New Hope (MN); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Employer-paid life/AD&D and disability

4% 401(k) employer match

Tuition reimbursement

Scholarship program for dependents

Employee referral bonus

Ongoing development opportunities

Job summary

Medical Manufacturing Technologies is seeking a Director of New Product Development in the Minneapolis area. You will build and lead a new NPD team, define product roadmaps, and drive machines from concept to first customer shipment, with hands-on design review, prototyping, and validation.

You will collaborate with Sales, Service, and Engineering, ensuring IQ/OQ/PQ compliance, data integrity, and scalable manufacturing handoffs while growing the team and shaping the development process.

Qualifications

• 12+ years in medical device manufacturing or development, including significant OEM experience.
• 5+ years leading engineers or cross-functional programs with direct responsibility for technical results.
• Track record of taking equipment, process technology, or products from concept to production.
• Practical knowledge of FDA-regulated environments (21 CFR 820 QMSR / ISO 13485, IQ/OQ/PQ).
• Comfort working directly with customers and executives, translating technical detail into a business case.

Responsibilities

• Talk directly with medical device manufacturers to identify unmet process, throughput, quality, and automation needs.
• Turn those needs into product concepts, business cases, and a prioritized roadmap with Sales, Service, and Product Management.
• Assess feasibility, costs, competing equipment, ROI, IRR, and payback before resourcing.
• Own new machine programs from concept through design, prototype, build, test, and launch.
• Write and approve product requirements and specifications; lead design reviews.
• Get hands-on with mechanical, controls, software, and process engineering challenges.
• Run customer trials and process development to prove machine performance on real parts.
• Ensure machines meet validation needs of regulated customers (IQ/OQ/PQ) and maintain data traceability.
• Hire, develop, and lead a team of engineers; decide which skills to build in-house or via partners.
• Set up a lightweight, stage-gated development process moving quickly while not skipping steps.
• Manage program budgets, schedules, resources; report progress to senior leadership.
• Collaborate with Operations to hand off designs for cost-effective, quality manufacturing.

Skills

Customer interaction

Leadership

Strategic roadmapping

Regulatory understanding

Communication

Education

Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or Electrical Engineering

Master’s degree in engineering or MBA (nice to have)

Job description

Medical Manufacturing Technologies is seeking a Director of New Product Development in the Minneapolis area. You will build and lead a new NPD team, define product roadmaps, and drive machines from concept to first customer shipment, with hands-on design review, prototyping, and validation.

You will collaborate with Sales, Service, and Engineering, ensuring IQ/OQ/PQ compliance, data integrity, and scalable manufacturing handoffs while growing the team and shaping the development process.