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