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