Senior Director, NPI Engineering & Medical Device Launch

Resonetics; Fridley (MN); On-site; USD 177,000 - 243,000; Full time

Job summary

Resonetics is seeking a Sr. Director of New Product Introduction to lead the end-to-end transition of medical device products from development to scalable, compliant manufacturing.

You will work at the intersection of R&D, Quality, Regulatory, and Operations to ensure rapid, safe, and reliable product launches. In a volatile environment, you’ll establish resilient systems, drive cross-functional alignment, and build an organization capable of executing under uncertainty while delivering

Qualifications

• Bachelor’s degree in Engineering with 15+ years leading large teams.
• 15+ years in senior leadership overseeing NPI, operations and engineering.
• Deep expertise in FDA regulations, ISO 13485 and design controls.
• Experience launching diverse, highly regulated medical devices.

Responsibilities

• Define and execute the enterprise NPI strategy aligned with growth, regulatory requirements, and market needs.
• Build a scalable NPI operating model for high variability and tight timelines.
• Lead cross-functional NPI teams across engineering, quality, regulatory, supply chain and manufacturing.
• Oversee design transfer, process validation, and risk mitigation for launches.
• Establish contingency strategies and drive stage-gate governance and KPIs.

Skills

Strategic leadership

Cross-functional leadership

Regulatory compliance

Risk management

Program management

Education

Bachelor’s degree in Engineering

Job description

Resonetics is seeking a Sr. Director of New Product Introduction to lead the end-to-end transition of medical device products from development to scalable, compliant manufacturing.

You will work at the intersection of R&D, Quality, Regulatory, and Operations to ensure rapid, safe, and reliable product launches. In a volatile environment, you’ll establish resilient systems, drive cross-functional alignment, and build an organization capable of executing under uncertainty while delivering