Specialist II, Engineering

Job Description

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 basic to intermediate statistical tools, with input from engineering staff.
• Write test protocols and reports, with input from engineering staff.
• 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, if applicable.
• Meet project goals with guidance.
• 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 additional duties as assigned.
  
  

Qualifications

• Associate degree or technical certification in a related field by an accredited body or an equivalent combination of education and years of related experience.
• Minimum seven (7) years of progressive experience as a technician or in a similar capacity.
• Strong written and verbal communication skills.
• Ability to read, write and speak in English.
• Well-organized and able to work in a fast-paced, self-directed environment.
• Strong computer skills in MS Word, Excel, Outlook, Teams, and related programs.
• Good laboratory and manufacturing practices and ability to follow required safety procedures.
  
  

Desired Qualifications

• Bachelor’s degree in applicable science-related field.
• Ability to read, redline and create Basic Drawings (BD), Manufacturing Processing (MP), Build Records (BR), and Quality Systems (QS).
• Ability to write and procure equipment to execute testing.
• Broad knowledge of the engineering or technical field, with the ability to read and prepare technical documentation.
• Machine-building or equipment tooling skills.
• Knowledge of medical and technical development.
• Strong knowledge of Good Laboratory Practices.
• Experience in the medical device industry.
• Working knowledge of CAD software platforms such as SolidWorks.