Chief Engineer

About the position

An exciting opportunity has become available within the medical device industry, for a Chief Engineer. The position is based in Cape Town.

REQUIREMENTS:

• 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

RESPONSIBILITIES:

• 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

Desired Skills:

• Chief Engineer
• Medical Devices
• Mechanical Engineering
• Biomedical Engineering
• Medical Device Regulations
• Research and Development

Desired Work Experience:

• More than 10 years

Desired Qualification Level:

• Masters