Director - New Product Design
Director, New Product Development
Location: Prefered Onsite (Or Remote in Midwest Region)
Overview
This is a leadership opportunity within a growing medical device organization undergoing a strategic shift to accelerate innovation and expand its new product pipeline. The role will be responsible for building and executing a scalable new product development function, partnering closely with executive leadership to drive organic revenue growth through differentiated product launches.
Key Responsibilities
- Define and execute the new product development roadmap aligned with commercial strategy
- Own the full product lifecycle from concept, feasibility, and design through commercialization
- Lead and scale an engineering team (current team in place with planned expansion)
- Drive execution of a prioritized product pipeline, ensuring on-time and on-budget delivery
- Implement and manage stage-gate processes, portfolio reviews, and resource planning
- Ensure compliance with design controls, FDA regulations, and applicable global standards
- Lead risk management activities including FMEA, usability, and human factors engineering
- Partner cross-functionally with Marketing, Regulatory, Quality, Operations, and Finance
- Collaborate with upstream teams to translate market needs into viable product opportunities
- Support development of technical documentation and regulatory strategies (e.g., 510(k), De Novo)
- Drive design transfer to manufacturing and ensure scalability of production processes
- Identify and manage external partners including contract manufacturers and design firms
- Engage clinical stakeholders and key opinion leaders to inform product development
Team & Scope
- Lead a growing NPD team (current team of engineers with planned expansion)
- Responsible for building team structure, capabilities, and long-term scalability
- High visibility role with regular interaction with senior and executive leadership
Qualifications
- 10+ years of medical device product development experience
- 5+ years of leadership experience managing engineering or NPD teams
- Proven track record leading products from concept through commercialization
- Strong knowledge of design controls, FDA 21 CFR Part 820, and ISO 13485
- Experience with complex medical devices (capital equipment, electro-mechanical, or similar)
- Familiarity across both complex and more straightforward product categories
- Background working with regulatory bodies and global product approvals
- Strong project management and stage-gate experience
Preferred
- Advanced degree (MS, MBA) or project management certification
- Experience in surgical, OR, or sterile/disposable product environments
- Exposure to global markets and international regulatory requirements
What We're Looking For
- Leader who can build structure in a growing, evolving environment
- Ability to balance speed and execution without overengineering processes
- Strong cross-functional collaborator with commercial and technical alignment
- Experience scaling teams and driving innovation within a regulated setting
- Strategic thinker who can connect product development to business growth
Why This Role
- Opportunity to build and scale a critical innovation function
- Direct impact on revenue through new product launches
- Highly visible position influencing company strategy
- Chance to shape processes, team, and pipeline during a growth phase
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