Sr. Director, NPI Engineering

Resonetics•Fridley, MN

3d•Onsite

About The Position

The Sr. Director of New Product Introduction (NPI) is responsible for leading the end-to-end transition of medical device products from development into scalable, compliant, and commercially viable manufacturing. This role operates at the intersection of R&D, Quality, Regulatory, and Operations, ensuring that new products are launched rapidly without compromising safety, compliance, or reliability. In a highly volatile environment—characterized by shifting regulatory expectations, evolving clinical requirements, supply chain disruptions, and aggressive timelines—the Sr. Director of NPI will establish resilient systems, drive cross-functional alignment, and build an organization capable of executing under uncertainty. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

Bachelor’s degree in Engineering
Minimum of 15 years of experience managing a team
7+ years in senior leadership roles overseeing NPI, Operations and engineering teams
Deep expertise in FDA regulations, ISO 13485 and design control processes
Proven track record of successfully launching technology platforms in highly regulated environments
Experienced in high-growth or highly volatile environments (e.g., startups, turnarounds or rapidly scaling organizations)
Strong background in both R&D and Operations
Experienced with complex devices (e.g., IPGs, delivery systems, complex therapy devices)
Decision-making under uncertainty – Able to move forward with incomplete data while managing risk
System thinking – understands interdependencies across design, manufacturing, and regulatory domains
Technology driven – Enforces the use and deployment of technology to simplify effort and improve output
Execution intensity – Drives outcomes in a fast-paced, high-pressure environments
Influence & alignment – Aligns diverse stakeholders with competing priorities
Risk management – Proactively identifies and mitigates technical, operational, and regulatory risks
Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 25 pounds at times.
Ability to differentiate between colored wires, tabs, and electronic components.
Must wear gown, gloves, and ear protection if applicable
Ability to handle and be trusted with confidential and/or sensitive information.
Able to work in a fast-paced, constantly changing environment.
Ability to be flexible and to handle multiple projects in an organized, timely manner.
Able to problem-solve, work under pressure, and to effectively manage stress.
Ability to work overtime if needed.
Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.

Responsibilities

Define and execute the enterprise NPI strategy aligned with business growth, regulatory requirements, and market demands.
Build a scalable, repeatable NPI operating model that performs under high variability and compressed timelines.
Partner with executive leadership to balance speed-to-market, cost, and quality risk.
Lead cross-functional NPI teams spanning Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Program Management.
Ensure seamless design transfer from R&D into manufacturing with robust process validation and risk mitigation.
Drive early manufacturability (DFM/DFA) and supply chain readiness during product development.
Develop systems to manage uncertainty, including rapid design iteration, supplier instability, and regulatory ambiguity.
Implement risk-based decision frameworks to enable speed without compromising compliance or patient safety.
Establish contingency strategies for critical components, processes, and suppliers.
Ensure all NPI activities comply with FDA, ISO 13485, and global regulatory requirements.
Partner with Quality and Regulatory teams to embed compliance into development and transfer processes.
Oversee successful execution of design controls, process validation (IQ/OQ/PQ), and product launches.
Oversee NPI program governance, prioritization, and resource allocation across multiple concurrent programs.
Implement clear stage-gate processes with measurable exit criteria.
Drive accountability for timelines, cost targets, and launch readiness metrics.
Ensure supplier qualification, capacity planning, and cost targets are achieved prior to launch.
Lead ramp-up strategies from pilot builds to full-scale production.
Drive resilience in global supply chains, including dual sourcing and risk mitigation.
Build and lead a high-performing NPI organization, including program managers, engineers, and operations leaders.
Foster a culture of urgency, accountability, and data-driven decision-making.
Develop leadership bench strength and succession planning within the NPI function.