Lead Biomedical Design Engineer - Western Cape, Observatory - Observatory
Zeal HR
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.
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