Sr. Director, NPI Engineering

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

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

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.

Responsibilities

Strategic Leadership

• 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.

Cross-Functional Execution

• 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.

Operational Excellence in Volatile Environments

• 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.

Regulatory & Quality Integration

• 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.

Program & Portfolio Management

• 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.

Supply Chain & Manufacturing Readiness

• 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.

Team Leadership & Development

• 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.

Key Performance Indicators (KPIs)

• Time-to-market for new products
• First-pass yield at launch
• Number and severity of post-launch quality issues
• Successful completion of stage gate IV launching into process validations
• Cost vs. target at production ramp
• Supply chain readiness and continuity
• Regulatory approval and audit outcomes

Required Qualifications

• 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

Physical Demands

• 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.

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $177,000–$243,000.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.