Director, Medical Device New Product Development

Colonial Group; Caledonia (MI); On-site; USD 150,000 - 230,000; Full time

Job summary

Aspen Surgical in the United States seeks a Director of New Product Development to drive ideation, development, and commercialization across the portfolio. You will expand the engineering team, build a robust pipeline, and partner with Marketing, Regulatory, Quality, and Operations to meet rigorous clinical, regulatory, and market requirements.

This change-oriented leader will create structure from ambiguity, move quickly, and build cross-functional credibility to advance priorities.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Sciences, or related field.
• 10+ years of medical device product development experience, including 5+ years in a team leadership role.
• Proven track record of FDA-cleared or approved product launches.
• Deep knowledge of design controls, 21 CFR Part 820, and ISO 13485.
• Strong project management and stage-gate methodology experience.
• Experience with international product approval processes and required documentation.

Responsibilities

• Define and execute the new product development roadmap in alignment with the commercial strategy set by the VP, Marketing & Product Development.
• Partner with Marketing and Sales to identify unmet clinical needs and prioritize the development pipeline.
• Lead project pipeline reviews, stage-gate processes and portfolio reviews with senior and executive leadership.
• Develop and lead an expanded NPD team, currently comprising one manager and four engineers.
• Assess team structure and capabilities; design and build the organization as the portfolio and pipeline expand.
• Foster a culture of innovation, accountability, and continuous improvement across the team.
• Manage resource allocation and capacity planning across concurrent development programs.
• Oversee all phases of design and development — from concept through commercialization — in compliance with design control requirements.
• Ensure on-time, on-budget delivery of product launches with appropriate clinical and technical validation.
• Lead risk management activities including design FMEAs, usability studies, and human factors engineering.
• Collaborate with Regulatory Affairs to define submission strategies (510(k), De Novo, etc.) and support technical documentation.
• Champion compliance with FDA 21 CFR Part 820, ISO 13485, and applicable international standards.
• Partner with Operations to ensure robust design transfer processes and manufacturing scalability.
• Identify and manage external development partners, contract design firms, and technology licensors.
• Engage key opinion leaders and surgeon advisory boards for clinical input and product validation.
• Stay current with emerging technologies, best practices, and industry trends, including the application of AI to accelerate development processes and improve design quality.

Skills

Strategic leadership

Project management

FDA regulations

Design controls

Stage-gate process

Cross-functional collaboration

Medical device development

Team building

Education

Bachelor’s degree in Engineering/Biomedical Sciences

Advanced degree (MS, MBA)

PMP certification

Job description

Aspen Surgical in the United States seeks a Director of New Product Development to drive ideation, development, and commercialization across the portfolio. You will expand the engineering team, build a robust pipeline, and partner with Marketing, Regulatory, Quality, and Operations to meet rigorous clinical, regulatory, and market requirements.

This change-oriented leader will create structure from ambiguity, move quickly, and build cross-functional credibility to advance priorities.