Mechanical Engineer - London

We are looking for a mechanical engineer with at least three years of experience in medical device development. The successful candidate will immediately take ownership of the mechanical aspects of the product and manage a team that is expected to grow quickly.

Key Responsibilities:

• Initially, you will capture the product’s design specifications and become familiar with the existing design. As the project evolves, you will work with the CTO and the electrical engineer to refine design requirements through surgeon feedback and market research.
• Continue the product’s mechanical design, which may involve ideation, CAD modelling, drawing generation, assembly, and testing. You will oversee junior team members and external contributors in this effort.
• Plan and document the product development process and collaborate with regulatory bodies, testing facilities, and consultants as needed.
• Work closely with a regulatory specialist to ensure that the development process complies with the Quality Management System (QMS).
• Support the transition from concept to design for manufacturing, Verification and Validation testing, and eventual product launch.

Essential Skills and Experience:

• Product development experience, including:
• Capturing design requirements.
• Ideation and rough prototyping.
• CAD solid modeling (e.g., SolidWorks), tolerancing, and drawing/print generation.
• A solid understanding of common manufacturing techniques (e.g., CNC machining, CNC turning, injection molding) and their advantages/limitations.
• Familiarity with quality and regulatory requirements for medical device design, including:
• US and EU/UK device classifications.
• Key regulations such as MDD/MDR, UK CA, EU CE, US CFR21.
• Key electro-mechanical ISO standards (e.g., BS EN ISO 60601-1:12)

Apply or email me directly - [email protected]