What are the responsibilities and job description for the Research And Development Engineer position at LanceSoft, Inc.?
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
Salary : $30 - $40