Sr. Director, NPI Engineering

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 environmentcharacterized by shifting regulatory expectations evolving clinical requirements supply chain disruptions and aggressive timelinesthe 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 thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fast-paced environment wed 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)

• 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

• Bachelors 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.

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $177000$243000.
• 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.