ASP Global
Director of Research & Development (R&D) (60832)
ASP Global, Austell, Georgia, United States, 30001
Job Details
Job Location : AUSTELL, GA 30168
Position Type : Full Time
Education Level : 4 Year Degree
Travel Percentage : Up to 25%
Job Summary:
We areseekingan experienced and strategic Director of Research & Development (R&D)to lead innovation and product development in the healthcare and medical device industry. This roleis responsible fordriving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions tomarket. The ideal candidate will have a strong background in Class I and Class II medical device development, regulatory frameworks (FDA, MDR, ISO 13485), and R&D leadership.
Key Responsibilities
Strategic Leadership:Develop and execute the R&D roadmap aligned withbusinessobjectivesand market needs, focusing on Class I and Class II medical devices.
Innovation & Product Development:Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies.
Regulatory & Quality Compliance: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.
Cross-Functional Collaboration:Work closely with engineering,quality, regulatory, marketing, andcontractmanufacturing teams to streamline product development from concept to commercialization.
Project Management:Establishand track project timelines, budgets, and deliverables while ensuring alignment with company goals.
Technology Scouting & Partnerships:Identifyemerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities.
Team Leadership & Development:Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration.
Risk Management:Assess technical and regulatory risks, implementing mitigation strategies to ensure project success.
Qualifications Qualifications & Requirements:
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 Qualifications:
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.
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Position Type : Full Time
Education Level : 4 Year Degree
Travel Percentage : Up to 25%
Job Summary:
We areseekingan experienced and strategic Director of Research & Development (R&D)to lead innovation and product development in the healthcare and medical device industry. This roleis responsible fordriving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions tomarket. The ideal candidate will have a strong background in Class I and Class II medical device development, regulatory frameworks (FDA, MDR, ISO 13485), and R&D leadership.
Key Responsibilities
Strategic Leadership:Develop and execute the R&D roadmap aligned withbusinessobjectivesand market needs, focusing on Class I and Class II medical devices.
Innovation & Product Development:Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies.
Regulatory & Quality Compliance: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.
Cross-Functional Collaboration:Work closely with engineering,quality, regulatory, marketing, andcontractmanufacturing teams to streamline product development from concept to commercialization.
Project Management:Establishand track project timelines, budgets, and deliverables while ensuring alignment with company goals.
Technology Scouting & Partnerships:Identifyemerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities.
Team Leadership & Development:Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration.
Risk Management:Assess technical and regulatory risks, implementing mitigation strategies to ensure project success.
Qualifications Qualifications & Requirements:
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 Qualifications:
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.
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