Senior Medical Device Verification Engineer – Test & Compliance

Gener8 | The RND Group; Washington (District of Columbia); On-site; USD 85,000 - 110,000; Full time

Job summary

Gener8 | The RND Group is seeking a QA/Test Engineer to generate test cases from requirements for medical instruments and execute them, producing execution reports. The role requires learning FDA 510(k) evidence gathering and familiarity with FDA 21 CFR Part 820, IEC 62304, and ISO standards.

You will work on FDA-regulated projects and contribute to defect tracking and quality systems compliance. The successful candidate will demonstrate experience with quality systems and strong communication

Qualifications

• Write test cases from requirements for medical instruments.
• Execute tests and generate execution reports.
• Create and maintain a traceability matrix.
• Defect tracking and management process.
• Familiarity with FDA 510(k) evidence requirements.

Responsibilities

• Generate test cases from requirements documents.
• Execute test cases and document results.
• Maintain traceability matrices for requirements.
• Participate in defect logging and resolution.
• Ensure compliance with quality system standards.

Skills

Write test cases

Execute tests

Traceability matrix

Defect tracking

Documentation process

Quality systems

Communication

Education

AS Degree

Job description

Gener8 | The RND Group is seeking a QA/Test Engineer to generate test cases from requirements for medical instruments and execute them, producing execution reports. The role requires learning FDA 510(k) evidence gathering and familiarity with FDA 21 CFR Part 820, IEC 62304, and ISO standards.

You will work on FDA-regulated projects and contribute to defect tracking and quality systems compliance. The successful candidate will demonstrate experience with quality systems and strong communication