Lead Biomedical Design Engineer

About the position

Are you a specialist Design Engineer in the Biomedical field, looking for your next challenge to make a difference?

This candidate will be an integral part of an interdisciplinary team of Scientists, Engineers, Clinicians, Technologists and Regulatorypersonnel in developing transcatheter heart valve replacements and deployment systems.

Key Responsibilities
1. Product design and development with a specific focus on
transcatheter heart valve deployment system R&D and
Production processes.
2. Perform design reviews.
3. Anticipate, mitigate and manage project risks.
4. Manage the operational aspects of the team of 4+
engineers.
5. Liaise with Production, Testing and Valve Teams.
6. Liaise and coordinate manufacturing refinements with the
Manufacturing Engineering team.
7. Liaise with stock control and ordering staff to ensure
optimum stock levels of components and timely orders of
new components - especially with extended lead times on
items such as frames.
8. Anticipate and manage risk to the delivery device
production process - in conjunction with Production and
Manufacturing Engineering, as regards people and
equipment.
9. Ensure compliance and due diligence with regulatory
standards and Design & Development processes.
10. Continually seek to help streamline manufacturing
efficiency, digitization, workflow and planning.
11. Develop manufacturing drawings following applicable
company standards using Solidworks
12. Interface with Surgeons, Customers, Vendors, Production
Managers & Procurement to find optimal solutions.
13. Set up test protocols and orderly documenting of all
developments/experiments run.
14. Maintaining design history and technical file
documentation.
15. Compliance with medical device regulatory requirements.

About the candidate:
? [URL Removed] or [URL Removed] in Mechanical/Biomedical Engineering
? At least 5 years of design experience
? Proficient in 3-D CAD software (preferably Solidworks)
? Can work independently and lead a team
? Good communication skills (verbal and written)

Desired Skills:

• Medical Device Design

Desired Work Experience:

• 5 to 10 years

Desired Qualification Level:

• Degree

About The Employer:

The company was established to develop medical devices that address the needs of up to 40 million patients worldwide. It is their mission to make a difference through developing medical device solutions in South Africa and the broader african region at an affordable price.