Verification Lead

Gener8 | The RND Group; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Gener8 | The RND Group in Indianapolis, IN is seeking a lead software tester for FDA-regulated medical devices. The role requires guiding testing activities and coordinating a testing team to ensure compliance and quality.

You will develop test cases from requirements, execute tests, and generate execution reports while gathering evidence for 510(k) submissions. Familiarity with FDA 21 CFR Part 820 and IEC 62304 is essential.

Qualifications

• Experience leading test efforts for software products.
• Ability to generate test cases from requirements for medical instruments.
• Experience executing tests and producing execution reports.
• Familiarity with evidence gathering for FDA submissions.
• Knowledge of FDA 21 CFR Part 820 and IEC 62304 is a plus.

Responsibilities

• Lead testing activities and supervise other testers as needed.
• Develop and maintain a traceability matrix.
• Execute test cases and generate detailed execution reports.
• Coordinate with stakeholders for documentation required for 510(k) submissions.
• Maintain alignment with FDA quality system regulations and IEC standards.

Skills

Lead testing experience

Test plan writing

Test case writing

Test execution

Traceability matrix

Defect tracking

Documentation process

Quality systems - ISO 14971

Quality systems - ISO 9000

IEC 62304

Communication skills

Project management

Education

Bachelor's degree in Biotechnology or related

Job description

Job Description

The successful candidate will have experience performing the lead role in testing a software product. The lead role should have included being the person primarily responsible for testing of the software product with optional supervision of other testers. The successful candidate should have experience generating test cases from requirements documents for medical instruments. The candidate will also be responsible for executing test cases and generating execution reports. The candidate must be familiar with the requirements for evidence gathering necessary for 510K submissions.

The majority of RND’s clients develop medical devices regulated by the FDA. The successful candidate will be able to quickly learn about FDA 21 CFR Part 820 – Quality System Regulation and IEC 62304 Software Development Lifecycle.

Required Skills And Qualifications

• Experience writing testing plans
• Experience writing test cases
• Experience executing tests
• Experience creating and maintaining a trace matrix
• Experience with defect tracking and defect management
• Understanding of formal documentation process
• Experience with quality systems – ISO 14971, ISO 9000, IEC 63xxx
• A 4 year BS Degree in Biotechnology or related is required
• Minimum of 6 years’ experience is required.
• Demonstrated leadership and project management skills are required
• Excellent oral and written communication skills are required

About RND

RND is a highly specialized software engineering firm dedicated to the FDA regulated medical device market. We work with companies by partnering with their product development organizations in providing project management, requirements management, software engineering, and product testing services as needed to complement our clients’ existing engineering departments.

RND develops software to assist with our client’s Next Generation medical device platforms and instruments. These platforms and instruments provide “breakthrough” technologies that are used to diagnose cancer and other diseases, develop personalized medicines, provide gene sequencing, and perform research to assist with developing other healthcare solutions.

Gener8 | The RND Group

5975 Castle Creek Pkwy N Dr, Ste 250
Indianapolis, IN 46250 317-841-8070

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