Sr Specialist, Engineering
Performs medium sized and intermediate complex aspects of product/processes development. Based on new product concepts and designs from Engineers, supports development of products/processes for medical devices; writing or verifying specifications and/or manufacturing procedures, designing new products, designing fixtures, test processes, equipment and raw materials to ensure concepts and/or prototypes meet product/processes 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 analyzes test results data using up to advanced statistical tools.
- Write test protocols, reports and justification documents for regulatory submissions.
- Set-up, adjusts and operates laboratory equipment and instruments.
- Provide technical direction to Technicians and Engineer 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 supports patent development, if applicable.
- Capable of developing project plan with guidance from Project Managers.
- Self-directed and capable of meeting project goals.
- Support production or process development as required.
- Perform other duties and projects as required.
- Associate degree or technical certification in a technical discipline such as Manufacturing, Electronics, Welding Technology, Machinist or similar experience.
- Three (3) to five (5) years of Engineering Specialist II experience, or equivalent related experience.
- Computer skills including Excel, Word, Minitab, SolidWorks.
- Bachelor’s degree in applicable Science related field.
- Ability to read, redline and create Basic Drawings (BD), Manufacturing Processing (MP), Build Records (BR) and QS
- Write and procure equipment to execute testing.
- Broad knowledge of the field, with the ability to read and prepare technical documentation. Knowledge of medical and technical development.
- Strong knowledge of Good Laboratory Practices.
- Provides mentorship and/or leadership support to project team members to guide, lead and work through challenges and remove roadblocks to meet project objecvtives and timelines.