Position Title: Engineer - Degreed III
Assignment Duration: 12 Months
Work Arrangement: Plano TX 75024

• Coordinate and work with external test houses for compliance testing of medical products
• Write and maintain compliance test plans and test reports
• Release and manage documentation within the company’s document control system
• Analyze changes to relevant standards and regulations
• Perform regulatory and compliance impact assessments on existing and new products.

Experience: 5-7 years of experience.

• Prior experience with medical device compliance testing highly desired
• Experience working with regulatory standards and external testing labs required
• 3-5 will consider but must have

Key Skills

• Medical device compliance and regulatory testing
•  Test plan development and reporting
• Standards and regulation analysis
• Documentation control and release processes
• Cross functional collaboration with test houses and internal teams

Preferred Experience:

• Hands-on experience with the following standards is strongly preferred; Manufacturing background is a plus

Radio / Wireless:
• EN 300 328
• FCC 15.247
• EN 301 489 1 / EN 301 489 17

Implantable Devices:
• ISO 14708 1
• ISO 14708 3
• Non Implantable Medical Devices:
• IEC 60601 1
• IEC 60601 1 2
• EMC / Immunity:
• IEC 61000 4 series

Education: Bachelor’s degree in Engineering or a related technical field preferred

  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 33.00/daily.