Validation Engineer
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Title: EMC/Compliance testing Engineer
Location: Plano, TX
Duration: 12 Months
100% Onsite
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 years will consider but must have related experience
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
Consultants Eligible Benefits Upon Waiting Period
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High‑Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
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