Senior Director of NPI Engineering
Overview
You will lead end-to-end product transitions from development to scalable, compliant manufacturing at a global medical device manufacturer. You will own the NPI strategy, cross-functional execution with R&D, Quality, Regulatory, and Operations, and build resilient systems for volatile regulatory and supply chain conditions. This role blends strategic leadership with operational rigor, demanding expertise in FDA regulations, ISO 13485, and design controls. You will drive rapid launches while maintaining safety and compliance, and build a high-performing team capable of thriving under uncertainty.
What You'll Do10
- 1Define and execute the enterprise NPI strategy aligned with business growth, regulatory requirements, and market demands.
- 2Build a scalable, repeatable NPI operating model that performs under high variability and compressed timelines.
- 3Lead cross-functional NPI teams spanning Engineering, Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Program Management.
- 4Drive early manufacturability (DFM/DFA) and supply chain readiness during product development.
- 5Develop systems to manage uncertainty, including rapid design iteration, supplier instability, and regulatory ambiguity.
- 6Implement risk-based decision frameworks to enable speed without compromising compliance or patient safety.
- 7Ensure all NPI activities comply with FDA, ISO 13485, and global regulatory requirements.
- 8Oversee successful execution of design controls, process validation (IQ/OQ/PQ), and product launches.
- 9Oversee program governance, prioritization, and resource allocation across multiple concurrent programs.
- 10Build and lead a high-performing NPI organization, including program managers, engineers, and operations leaders.
Requirements9
- 1Bachelor's degree in Engineering
- 2Minimum of 15 years of experience managing a team
- 37+ years in senior leadership roles overseeing NPI, Operations, and engineering teams
- 4Deep expertise in FDA regulations, ISO 13485, and design control processes
- 5Proven track record of launching technology platforms in highly regulated environments
- 6Experienced in high-growth or highly volatile environments (e.g., startups, turnarounds, or rapidly scaling organizations)
- 7Strong background in both R&D and Operations
- 8Experienced with complex devices (e.g., IPGs, delivery systems, complex therapy devices)
- 9Decision-making under uncertainty, system thinking, technology-driven, execution intensity, influence and alignment, and risk management
Salary Insight
$177 - $243k per year
Location
Required Skills
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