Mechanical Engineer R&D Manager - Medical Devices JB-4382

A fast-growing medical device start-up is seeking a highly experienced R&D Manager to lead the mechanical and pneumatic development of our next generation product and oversee its transition to advanced manufacturing.

This is a unique opportunity to take part in developing a life-saving technology in a challenging and rewarding leadership role.

Key Responsibilities:

Lead the end-to-end development of complex medical devices aligned with the company’s vision and goals.

Actively contribute to the design, development, integration, and testing of the product throughout its lifecycle.

Manage engineering project timelines, task allocation, resource planning, and dependencies.

Plan and conduct design validations and verification activities to support regulatory submissions (e.g., FDA, MDR).

Prepare comprehensive documentation, including engineering reports, project plans, and presentations.

Identify and mitigate project risks through proactive planning and strategic execution.

B.Sc. in Mechanical Engineering from a leading university

Minimum 10 years of experience in product development management

At least 3 years of hands-on experience in medical device development

Proven track record of bringing regulated medical products to market (FDA, MDR)

Strong understanding of ISO 13485 and related quality standards

Deep experience in designing and developing pressure systems/components

Practical experience transitioning products from development to manufacturing

Proficiency in Agile project management methodologies

Basic understanding of software development and hardware-software interfaces - an advantage

Experience integrating electrical and electronic components in medical products - an advantage