Director, New Product Development

Talent Acquisition Team•Caledonia, MI

145d

About The Position

The Director, New Product Development, drives the ideation, development, and commercialization of innovative medical device products across Aspen Surgical’s portfolio. Reporting to the VP, Marketing & Product Development, this leader expands the engineering team and builds and executes a new product pipeline to deliver organic revenue growth. The Director has autonomy to build and organize the function as the business grows and partners closely with Marketing, Regulatory, Quality, and Operations to deliver differentiated products that meet clinical, regulatory, and market requirements. This change-oriented role calls for an established leader who can create structure from ambiguity, move quickly in a fast-paced environment, and build cross-functional credibility. The position leads the new product development roadmap, team, portfolio, and product programs from concept through commercialization. It includes responsibility for design controls, clinical and technical validation, risk management, regulatory strategies, design transfer, manufacturing scalability, and external development partners.

Requirements

Bachelor’s degree in Engineering, Biomedical Sciences, or a related field.
10+ years of medical device product development experience.
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.

Nice To Haves

Advanced degree, such as an MS or MBA, with PMP or equivalent project management certification.
Experience with OR workflow and sterile/single-use product environments.
Familiarity with SPD processes and the corresponding products required for sterile processing.
Familiarity with endoscope reprocessing and the standards and guidelines governing the process.
M&A integration or technology acquisition experience.

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 the expanded NPD team, currently comprising one manager and four engineers.
Assess team structure and capabilities and 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 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, including 510(k) and De Novo, 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 applying AI to accelerate development processes and improve design quality.