Engineer II / Scientist II

• Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings
• Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards
• Build test parts for engineering evaluation, pre-clinical studies and clinical studies
• assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate
• Supports new process equipment and tooling development, including specification development, vendor selection and negotiation
• prepare work instructions and standard operating procedures (SOP), write technical documents and reports
• Prepare raw material specifications and drawings
• Assist in preparing verification and validation protocols and reports
• develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians
• prepare and assist in the validation of test methods
• perform lab bench testing, conduct engineering and competitor evaluations, development unit testing, and execute verification and validation activities
• train technicians on new design and process development as well as new test methods
• Assist/conduct new process development training with operations and quality assurance
• Mentor/coach R&D technicians through New Product Development activities like new process development, R&D materials/inventory control etc
• May lead or manage technicians or engineering interns
• Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines
• Assist in design and process root cause analysis and support non-conforming product and complaint investigations

Bachelors degree in Engineering or Science plus 1 year of experience