Research And Development Engineer

Title: R&D Engineer/ Engineer - Degreed III

Location: Plano, TX – 75024

Duration: 12 Months

Description:

Duties:

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