Chief Engineer Observatory - Observatory
Zeal HR
An exciting opportunity has become available within the medical device industry, for a Chief Engineer. The position is based in Cape Town. Overall responsibility for all aspects of engineering design, materials & component testing, product manufacturing and technical documentation Advise and mentor all company staff who are involved with the technical aspects of company product development Control the delivery of quality of company products for pre-clinical animal testing and human implantation Understand technical characteristics of all company products and ensure that these are aligned with user needs and regulatory standards Work with the Lead Engineers to ensure that their collective and coordinated efforts are focused on clear attainable goals Support technical staff, especially Lead Engineers, and provide support and motivation to all engineering staff Advise the COO and Chairman on strategic decisions and their implantation related to technical matters Show leadership in dealing with any aspects of component failure or under-performance Work with COO (when necessary) to address technically-related HR issues Help write and edit all documents that are relevant to the Design History Files and which support filing of Intellectual Property (IP). Oversee, monitor and advise on issues relating to Intellectual Property portfolio of Company R&D related to the engineering aspects of company product development Testing of materials and components according to relevant national and international standards Failure analysis within R&D and prototype phases of product development Approval of all relevant technical documentation Approval of engineering decisions concerned with quality control and regulatory approval . Key Documentation/Regulations Produce: Write /Review / Approve of all relevant technical documentation for Design History Files and Regulatory Submissions Participation in writing scientific and technical papers for publication Consult: Discuss technical issues with external consultants Master's or other higher degree in scientific or engineering discipline An in depth understanding of the design and manufacture of implantable (Class III) medical devices Knowledge of Mechanical Engineering Knowledge of Biomedical Engineering Knowledge of Medical device regulation Planning of R&D projects Interpretation of scientific data Risk / benefit analysis Co-ordination of work of all technical personnel in the company Technical and scientific writing / editing Critical decision making Understanding the legal and ethical dimensions of medical technology Balance of authority and understanding when dealing with individual staff members Knowledge of the medical device industry, ideally cardiovascular Bringing experience, motivation and a positive environment for managing complex projects
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