Sr Specialist, Engineering

Perform medium sized and intermediate complex aspects of product/process development. Based on new product concepts and designs from engineers, support the development of products/processes for medical devices, including writing or verifying specifications and/or manufacturing procedures, designing fixtures and new products, and testing processes, equipment, and raw materials to ensure concepts and/or prototypes meet product/process development requirements.

Job duties: Technician Role: Perform set-up and testing of completed units or components under operational conditions to investigate designs or to obtain data for development, quality, or manufacturing. Record and analyze test results data using up to advanced statistical tools. Write test protocols, reports, and justification documents for regulatory submissions.

Set up, adjust, repair, and operate laboratory equipment and instruments, which may include electrical wiring and other components. Engineering Role: Provide technical direction to technicians and engineering specialists to meet project goals. Fabricate intermediate complex prototypes, manufacturing process, tools, and fixtures.

Create drawings for prototypes, manufacturing processes, tools, and fixtures. Generate intellectual property, writing invention disclosures and support patent development, if applicable. Develop project plan with guidance from Project Managers. Support production or process development as required. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

Perform other duties and projects as required.