R&D Engineering Leader – Delivery Systems

We are seeking a highly motivated and experienced R&D Engineering Leader to spearhead the development of innovative delivery system components within our organization.

Responsibilities:

• Team Leadership: Foster a collaborative and results-oriented work environment by providing effective leadership and mentorship to a team of talented engineers.
• Product Development: Oversee the entire product development lifecycle for assigned delivery system components, ensuring they meet all quality, performance, and regulatory requirements.
• Project Management: Concurrently manage multiple projects, prioritizing tasks, allocating resources, and effectively tracking progress towards defined milestones.
• Technical Expertise: Serve as a technical subject matter expert, providing guidance and solutions to complex engineering challenges faced by the team.
• Regulatory Compliance: Ensure unwavering adherence to all relevant regulatory standards and guidelines, including ISO 13485 and FDA QSR, throughout the development process.
• Cross-Functional Collaboration: Build and maintain strong working relationships with other functional teams such as Clinical Affairs, Manufacturing, and Quality Assurance, fostering seamless communication and collaboration.

Qualifications:

• Bachelor of Science (B.Sc.) degree in Mechanical Engineering or a closely related field.
• Minimum of four (4) years of demonstrably successful experience in medical device design and development.
• Strong technical expertise in the principles of mechanical engineering, encompassing materials science, stress analysis, and manufacturing processes.
• Proven leadership skills, with the ability to motivate, inspire, and cultivate the professional development of team members.
• Excellent project management and organizational skills, demonstrably effective in managing multiple projects concurrently.
• Strong communication and interpersonal skills, adept at facilitating collaborative team environments.
• Experience working within the framework of regulatory requirements and quality systems for medical devices.