Strategic Leader, Medical Device NPD & Innovation

Aspen Surgical; Caledonia (MI); On-site; USD 180,000 - 250,000; Full time

Job summary

Aspen Surgical is seeking a Director of New Product Development to lead ideation, development, and commercialization of cutting‑edge medical devices.

You will expand the engineering team, partner with Marketing, Regulatory, Quality, and Operations, and deliver FDA‑compliant products on schedule and budget. This leadership role requires building structure from ambiguity and earning cross‑functional credibility.

Qualifications

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

Responsibilities

• Define and execute the new product development roadmap aligned to strategy.
• Lead an expanded NPD team and build the organization as portfolio grows.
• Partner with Marketing, Regulatory, Quality, and Operations to deliver compliant products.
• Oversee design through commercialization and ensure on-time, on-budget launches.
• Manage resource allocation, risk management, and external development partners.

Skills

Leadership

New product development

FDA/regulatory knowledge

Design controls

Project management

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in Engineering, Biomedical or related field

Advanced degree (MS/MBA) preferred

Job description

Aspen Surgical is seeking a Director of New Product Development to lead ideation, development, and commercialization of cutting‑edge medical devices.

You will expand the engineering team, partner with Marketing, Regulatory, Quality, and Operations, and deliver FDA‑compliant products on schedule and budget. This leadership role requires building structure from ambiguity and earning cross‑functional credibility.