Responsible for developing, building, testing, and documenting of electromechanical and product and process activities in a regulated medical device environment.
The Principal/Senior Development Engineer or his authorised designee has the authority to act on behalf of the Development Technician.
• Defining and validation of Test Methods / Experimental Rigs / Process Equipment
• Preparation of samples for development tests
• Managing and supervising test lots on various electro and mechanical test set ups.
• Creation of or contribution to various documents supporting product and process development efforts such as test protocols and methods, engineering qualification and design verification and validation plans and completion of required reports.
• Documenting all results through lab-book entries or in the form of technical reports and presenting data in a concise and accurate manner.
• Support the introduction of new equipment and materials including installation, calibration and EHS assessment.
• Participation in department and project team meetings as required.
• Communicate regular and accurate updates on project deliverables to the project leader and/or Aerogen management. Communicate risk of divergence from plan to the project leader.
• Supporting Engineering personnel in various project and non-project activities
• Adherence to all Aerogen policies and the conditions as highlighted in the Aerogen Employee Handbook and Aerogen Quality Manual.
• Any other duties at the request of your Manager / Supervisor.
• Minimum of a Certificate plus three years’ relevant experience or a Degree plus one years’ relevant experience in an engineering or technology related discipline.
• Strong electro-mechanical knowledge and experience of engineering principles as applied to device manufacture.
• Experience in specification, manipulation, and characterization of a range of engineering materials.
• Ability to work on own initiative with minimum supervision.
• Meticulous attention to detail
• Strong scientific and technical awareness with an appetite to investigate and learn.
• Proficiency in use of desktop software applications such as MS office
• Good time management skills
• Excellent verbal and written communication skills
• Ability to work as part of a multi-disciplinary team with good interpersonal skills and in a laboratory environment.
• Methodical and analytical approach to work
• Ability to interpret engineering drawings.
• Previous work experience and working knowledge of lasers, their safety procedures, etc., would be an added advantage.
• Experience of using statistical software such as Minitab and CAD/3D Modelling software are distinct advantages.
• Typical Medical Device Design and Development Environment with work also performed in Development labs and Manufacturing areas in addition to customer/supplier locations.