Director, New Medical Device Development & Launch

Jobtome; Minneapolis (MN); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical/Dental/Vision

401(k) match

Tuition reimbursement

Dependent scholarship

Referral bonus

Development opportunities

Job summary

MMT seeks a Director of New Product Development to build and lead a new team creating next‑gen grinding, measurement, and automation equipment for medical device manufacturers. This player‑coach role involves shaping the program from concept to first customer shipment, writing specs, and aligning with Sales, Service, and Product Management.

You will hire and develop engineers, work with customers to translate needs into business cases, and ensure products meet regulatory validation requirements

Qualifications

• Bachelor's degree required in Mechanical, Biomedical, Manufacturing, or Electrical Engineering; equivalent experience considered.
• 12+ years in medical device manufacturing or development, including OEM experience.
• 5+ years leading engineers or cross‑functional programs with direct responsibility for technical results.
• Proven track record taking equipment or products from concept to production.
• Practical knowledge of specifying, purchasing, validating, and running process equipment in FDA-regulated settings (IQ/OQ/PQ).
• Ability to translate technical detail into a clear business case and engage with customers and executives.

Responsibilities

• Talk directly with medical device manufacturers to identify unmet process, throughput, quality, and automation needs.
• Transform needs into product concepts, business cases, and a prioritized roadmap with Sales, Service, and Product Management.
• Assess feasibility, cost targets, and ROI; decide on resource allocation.
• Own new machine programs from concept through design, prototype, build, test, and launch.
• Write and approve product requirements and specifications; lead design reviews.
• Engage hands-on in solving mechanical, controls, software, and process engineering challenges.
• Run customer trials and process development to validate performance on real parts.
• Ensure validation needs (IQ/OQ/PQ, documentation, traceability, data integrity) are met for regulated customers.
• Hire, develop, and lead a team of engineers; decide which skills are built in-house vs. via partners.
• Establish a lightweight, stage-gated development process that moves quickly while retaining key steps.
• Manage budgets, schedules, and resources; report progress to senior leadership.
• Collaborate with Operations to hand off designs for cost-effective, quality production.
• Prepare Sales and Service for launch with specs, demos, pricing input, training, and early support.
• Oversee full product lifecycle and plan end-of-life for existing platforms as new ones release.
• Partner with engineering teams at operating sites and support sustaining engineering projects.

Education

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

Master's degree in engineering or MBA

Leadership of engineers or cross‑functional programs

Customer-facing technical communication

Regulatory knowledge: FDA 21 CFR 820 QMSR / ISO 13485

Job description

MMT seeks a Director of New Product Development to build and lead a new team creating next‑gen grinding, measurement, and automation equipment for medical device manufacturers. This player‑coach role involves shaping the program from concept to first customer shipment, writing specs, and aligning with Sales, Service, and Product Management.

You will hire and develop engineers, work with customers to translate needs into business cases, and ensure products meet regulatory validation requirements