Note: The job is a remote job and is open to candidates in USA. Dice is hiring a Specialist II, Engineering to support medical device product and process development. The role involves testing designs and components, analyzing data, preparing technical documentation, fabricating prototypes, creating drawings, and providing technical direction to technicians and engineering specialists while supporting production and process development.
Responsibilities
- 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
- 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
Skills
- 1. Associate degree or technical certification in a related field by an accredited body or an equivalent combination of education and years of related experience
- 2. Minimum seven (7) years of progressive experience as a technician or in a similar capacity
- 3. Strong written and verbal communication skills
- 4. Ability to read, write and speak in English
- 5. Well-organized and able to work in a fast-paced, self-directed environment
- 6. Strong computer skills in MS Word, Excel, Outlook, Teams, and related programs
- 7. Good laboratory and manufacturing practices and ability to follow required safety procedures
- * Extended periods of computer use
- * Extended periods of standing or sitting
- * For certain tasks or areas, the ability to perform repetitive tasks under magnification or using a microscope for extended periods of time
- * Light lifting, up to 25 lbs
- * Manual dexterity and hand-eye coordination to complete required tasks
- * Gowning may be required in controlled environments. Personal Protective Equipment use, including safety glasses and gloves, required for certain tasks or areas
- * May work with machinery and chemicals, requiring strict adherence to safety protocols
- * May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs)
- 1. Bachelor's degree in applicable science-related field
- 2. Ability to read, redline and create Basic Drawings (BD), Manufacturing Processing (MP), Build Records (BR), and Quality Systems (QS)
- 3. Ability to write and procure equipment to execute testing
- 4. Broad knowledge of the engineering or technical field, with the ability to read and prepare technical documentation
- 5. Machine-building or equipment tooling skills
- 6. Knowledge of medical and technical development
- 7. Strong knowledge of Good Laboratory Practices
- 8. Experience in the medical device industry
- 9. Working knowledge of CAD software platforms such as SolidWorks
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