Job Summary

• 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.

Key Responsibilities

1. To create & review the Test Cases from the Functional Specifications / Software Requirement Specification document.
2. To test the Functionality as per the Test plan and respective Test Cases..
3. To contributes while test plans are developed as per the work assigned.
4. To track test coverage, defect density, other relevant metrics, and publish progress reports.
5. To coordinate with team (for discussions) and interact with client (for updates).

Skill Requirements

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Other Requirements

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