Director - New Product Development
Location: Remote to Midwest Candidates
Reports To: Vice President, Marketing & Product Development
About the Opportunity
An established and growing medical device company is seeking a Director, New Product Development to lead the strategy, development, and commercialization of innovative products across a diverse portfolio. This is a high-impact leadership opportunity for someone who thrives in building teams, creating structure, and driving new product innovation in a fast-paced, growth-oriented environment.
Reporting directly to the VP of Marketing & Product Development, this individual will play a critical role in shaping the product pipeline, expanding the engineering organization, and delivering commercially successful products that meet clinical, regulatory, and customer needs.
This role is ideal for a hands-on leader who can balance strategic planning with execution while effectively partnering across Marketing, Regulatory Affairs, Quality, Operations, and Commercial teams.
Key Responsibilities
- Define and execute the product development roadmap in alignment with commercial and business objectives.
- Partner with Marketing and Sales to identify unmet customer and clinical needs and prioritize development initiatives.
- Lead portfolio reviews, project pipeline management, and stage-gate processes with senior leadership.
- Build, develop, and mentor a growing team of product development leaders and engineers.
- Evaluate organizational capabilities and design team structures to support future growth.
- Foster a culture of accountability, innovation, collaboration, and continuous improvement.
- Manage resource allocation, project prioritization, and development capacity across multiple programs.
- Lead all phases of product development from concept through commercialization.
- Ensure compliance with design controls, quality system requirements, and applicable regulatory standards.
- Drive successful product launches that meet timeline, budget, and performance objectives.
- Oversee risk management activities, including design FMEA, human factors, usability studies, and product verification and validation.
- Partner with Regulatory Affairs on submission strategies and technical documentation efforts for domestic and international markets.
- Collaborate with Operations to ensure successful design transfer and scalable manufacturing processes.
- Manage external innovation partners, contract design firms, and technology development relationships.
- Engage key opinion leaders and clinical advisors to inform product development and validation activities.
- Monitor emerging technologies, industry trends, and AI-enabled development tools that can accelerate innovation and improve design quality.
Qualifications
Required
- Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical field.
- 10+ years of medical device product development experience.
- 5+ years of leadership experience managing engineering or product development teams.
- Demonstrated success leading FDA-cleared and/or approved product launches.
- Strong understanding of design controls, FDA quality system requirements, and ISO 13485.
- Experience leading cross-functional teams through structured product development processes.
- Knowledge of international regulatory requirements and product registration activities.
Preferred
- Master's degree, MBA, or other advanced degree.
- PMP certification or equivalent project management training.
- Experience developing products used in surgical, procedural, sterile processing, or healthcare environments.
- Familiarity with product reprocessing workflows and associated industry standards.
- Experience supporting acquisitions, technology integrations, or external innovation partnerships.
Key Requirements
- Engineering background; PMP preferred.
- Medical device experience across surgical disposables, capital equipment, and consumables ect.
- Strong product development and project management experience.
- Experience leading engineers and cross-functional teams.
- Proven success taking products from concept through commercialization.
- Familiarity with sterile processing workflows, single-use products, and SPD environments.
- Knowledge of endoscope reprocessing standards and guidelines.
- Experience with technology acquisitions, licensing, or M&A integration activities.
Leadership Profile
Successful candidates will demonstrate:
- Strategic thinking and business acumen
- Strong organizational leadership and team-building capabilities
- Executive-level communication and stakeholder management
- Ability to make decisions in ambiguous environments
- Cross-functional influence and collaboration
- Change management and organizational development experience
- Customer-focused and clinically driven decision-making
- Passion for innovation and continuous improvement
Why Consider This Opportunity?
- Visible leadership role with significant influence on company growth strategy.
- Opportunity to build and scale a product development organization.
- Direct ownership of product innovation and commercialization efforts.
- Broad cross-functional exposure and executive-level interaction.
- Strong platform for career growth within a growing medical device organization.
If you are passionate about developing innovative medical technologies and leading high-performing teams through the complete product development lifecycle, we encourage you to apply.