Senior Designer
United States
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Job Description
Senior Designer
Plano, Texas

Job Summary

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 · Excellent communication skills & interaction with multiple stake holders/functions · Must be familiar with software tools: Microsoft Word, Excel, PowerPoint

Key Responsibilities

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

· Prior experience with medical device compliance testing highly desired

· Experience working with regulatory standards and external testing labs required

· 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

· 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

· System understanding & trainings on existing products lines.

· Must be familiar with technical work instruction and drawings, and good documentation practices.

Skill Requirements

Medical device compliance and regulatory testing

Test plan development and reporting

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

EN 301 489 17

Non-Implantable Medical Devices: IEC 60601-1, IEC 60601-

1-2

Other Requirements

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Maximum Salary (US):  99000
Minimum Salary (US):  59000
Apply now
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion. 

 

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.