Job Description:
· Lead R&D Projects: Drive the design, development, and innovation of interventional medical devices, ensuring projects are completed on time, within scope, and budget.
· Product Development: Oversee the product development lifecycle including feasibility studies, prototyping, preclinical and clinical validation, design for manufacturability (DFM), and regulatory approvals.
· Technical Leadership: Provide technical direction, mentoring, and leadership to a multidisciplinary team of professionals and engineers.
· Collaboration: Work closely with cross-functional teams (clinical, regulatory, manufacturing, marketing, and quality) to ensure seamless product development and alignment with business goals.
· Regulatory Compliance: Ensure that products comply with relevant regulatory standards (e.g. FDA, CE Mark, ISO 13485) and manage interactions with regulatory bodies.
· Innovation and Strategy: Identify emerging trends and technologies in the interventional medical device field, incorporating them into product development strategies.
· Vendor and Partner Management: Collaborate with external partners, suppliers, and contract manufacturers to achieve product development goals.
· Budget and Resource Management: Manage the R&D budget, resource allocation, and project prioritization to optimize development efficiency and output.
· Risk Management: Identify and mitigate technical and project risks throughout the development process.
Requirements:
· Bachelor Degree in Biomedical Engineering, Mechanical Engineering, or related field. Master’s or Ph.D. preferred.
· Minimum of 10 years of experience in R&D within the medical device industry, with at least 5 years focused on interventional medical devices (e.g. catheters, stents, Sheaths, etc.).
· Proven track record of leading product development from concept to market launch.
· Strong knowledge of regulatory requirements and quality systems for medical devices (e.g., FDA, CE Marking, ISO 13485).
· Experience managing R&D teams, including engineers, scientists, and technical staff.
· Excellent leadership, communication, and organizational skills.
· Strong problem-solving abilities and a high level of technical competence in medical device engineering.
· Ability to manage multiple projects simultaneously, balancing technical challenges and business priorities.
· Familiarity with Design Control, Risk Management, and Human Factors Engineering processes.
