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An excellent opportunity has become available to join a leader within the Medical Device Manufacturing industry in the capacity of Lead Design Engineer. *Key role:* The Incumbent will be required to execute in a timeous manner the development of a medical device by facilitating the design and development of said device, including definition and delegation of design tasks, risk identification and control, adherence to company design control methodology as well as relevant local and international standards, functional and pre-clinical testing and simulations, and development of a technical documentation for regulatory submission. *Responsibilities:* * Product Lifecycle Management: * Research and Design: * Work as part of a team with the relevant stakeholders to identify potentially beneficial and profitable technologies/therapies * Work with the relevant clients/stakeholders to develop the client specifications and design features required of the technology/therapy * Explore potential intellectual property opportunities for identified technologies/therapies conceptualised * Work with the QA/RA team to identify any regulatory standards associated with the technology/therapy conceptualised * Prepare and lead formal and informal design reviews with internal and external clients and stakeholders * Work as part of an Engineering team to prepare prototypes, drawings and simulations based on regulatory/client specifications and within time and budget constraints. * Execute sound problem-solving practices to solve design issues. * Support the Production team by designing first-generation production and quality assurance tools and equipment * * Development: * Facilitate and oversee early stage concept development and feasibility prototypes and simulations * Facilitate and oversee analysis and critical review of the conceptual phase and the selection of the design(s) to advance to detailed design phase * Identify appropriate materials for the devices and facilitate the development of the supply chain of these materials * Maintain the agreed project budget and timeline and communicate any deviations/delays to the relevant stakeholders * Proactively present/share ideas and problem-solving recommendations. * Lead continuous improvement activities including process optimisation/contributing to procedural requirements/updates as needed. * Develop and maintain a level of knowledge and competence/area of expertise * * Testing and Validation: * Facilitate and oversee the design and development of benchtop tests or simulations for the device in line with the relevant national and international standards where applicable and possible * Test the devices concerned for compliance with relevant national or international standards * Work with the relevant stakeholders to draft/formulate applications to the relevant https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly9lbi16YS53aGF0am9icy5jb20vY29vcG9iX19jcGxfX18xNTU1XzQzOTk0X180OTc/dXRtX3NvdXJjZT1ndW10cmVlJnV0bV9tZWRpdW09ZmVlZCZrZXl3b3JkPQ==&jid=1233860&xid=1555_43994

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An excellent opportunity has become available to join a leader within the Medical Device Manufacturing industry in the capacity of Lead Design Engineer. *Key role:* The Incumbent will be required to execute in a timeous manner the development of a medical device by facilitating the design and development of said device, including definition and delegation of design tasks, risk identification and control, adherence to company design control methodology as well as relevant local and international standards, functional and pre-clinical testing and simulations, and development of a technical documentation for regulatory submission. *Responsibilities:* * Product Lifecycle Management: * Research and Design: * Work as part of a team with the relevant stakeholders to identify potentially beneficial and profitable technologies/therapies * Work with the relevant clients/stakeholders to develop the client specifications and design features required of the technology/therapy * Explore potential intellectual property opportunities for identified technologies/therapies conceptualised * Work with the QA/RA team to identify any regulatory standards associated with the technology/therapy conceptualised * Prepare and lead formal and informal design reviews with internal and external clients and stakeholders * Work as part of an Engineering team to prepare prototypes, drawings and simulations based on regulatory/client specifications and within time and budget constraints. * Execute sound problem-solving practices to solve design issues. * Support the Production team by designing first-generation production and quality assurance tools and equipment * * Development: * Facilitate and oversee early stage concept development and feasibility prototypes and simulations * Facilitate and oversee analysis and critical review of the conceptual phase and the selection of the design(s) to advance to detailed design phase * Identify appropriate materials for the devices and facilitate the development of the supply chain of these materials * Maintain the agreed project budget and timeline and communicate any deviations/delays to the relevant stakeholders * Proactively present/share ideas and problem-solving recommendations. * Lead continuous improvement activities including process optimisation/contributing to procedural requirements/updates as needed. * Develop and maintain a level of knowledge and competence/area of expertise * * Testing and Validation: * Facilitate and oversee the design and development of benchtop tests or simulations for the device in line with the relevant national and international standards where applicable and possible * Test the devices concerned for compliance with relevant national or international standards * Work with the relevant stakeholders to draft/formulate applications to the relevant https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly9lbi16YS53aGF0am9icy5jb20vY29vcG9iX19jcGxfX18xNTU1XzE1OTU2X180OTc/dXRtX3NvdXJjZT1ndW10cmVlJnV0bV9tZWRpdW09ZmVlZCZrZXl3b3JkPQ==&jid=1170673&xid=1555_15956

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