Sr. Director, NPI Engineering

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.

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)

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