ASP Global · 1 month ago
Director of Research & Development (R&D) (60832)
AUSTELL, GA 30168
Full-time
Onsite
Director/Executive
10+ years expASP Global is seeking an experienced and strategic Director of Research & Development (R&D) to lead innovation and product development in the healthcare and medical device industry. This role is responsible for driving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions to market.
Medical
Responsibilities
Develop and execute the R&D roadmap aligned with business objectives and market needs, focusing on Class I and Class II medical devices
Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies
Ensure compliance with regulatory requirements, including FDA 510(k), CE Mark, MDR, and ISO 13485. Collaborate with regulatory and quality teams to support submissions and audits
Work closely with engineering, quality, regulatory, marketing, and contract manufacturing teams to streamline product development from concept to commercialization
Establish and track project timelines, budgets, and deliverables while ensuring alignment with company goals
Identify emerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities
Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration
Assess technical and regulatory risks, implementing mitigation strategies to ensure project success
Qualification
Required
Education: Minimum Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Life Sciences, or a related field
Experience: Minimum 10+ years of experience in R&D leadership within the medical device or healthcare industry, specifically in Class I and II devices
Technical Expertise: Strong knowledge of Class I and II medical device design, biomaterials, manufacturing processes, and relevant regulatory pathways
Regulatory Knowledge: Experience with FDA 510(k), MDR, ISO 13485, and GMP requirements for Class I and II medical devices
Project & Budget Management: Proven track record in leading multiple projects within time and budget constraints
Leadership Skills: Demonstrated ability to lead cross-functional teams and drive innovative solutions
Communication & Problem-Solving: Strong analytical, decision-making, and communication skills
Preferred
Experience in med-surgical devices including: operating room, intensive care unit
Prior experience in leading R&D in a startup or high-growth environment
Knowledge of clinical trials, human factors engineering, and reimbursement strategies for Class I and II devices
Company
ASP Global
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Incline Equity Partners
2024-08-06Acquired
2020-02-11Private Equity
Leadership Team
Doug Shaver
Chief Executive Officer
Justin Martin
Chief Product Officer & General Manager, Injury Prevention
Recent News
2023-06-13
Company data provided by crunchbase