Essential Duties and Responsibilities
- Analyze user needs and requirements.
- Design testing strategies and detailed test plans for functional verification at module, unit, and system levels to ensure that product requirements, quality system requirements, regulatory requirements, and design specifications have been met.
- Document test plans, acceptance criteria and test results.
- Write and execute system and software verification and validation tests.
- Effectively record, reproduce, and communicate software and hardware bugs to development staff and contribute to their resolution.
- Review and author design control documents.
- Work with external vendors to verify and validate software and hardware platforms.
- Contribute to system design history files.
- Troubleshoot system issues and failures.
- Bachelor’s degree in a science or technology field or equivalent work experience.
- Three (3) years of experience with system and/or software testing.
- Familiarity with laboratory instrumentation and procedures.
- Proficient with Microsoft Office, Including Project, Word, Excel, and PowerPoint.
- Basic fluency in a programming language, preferably C# and SQL
- Ability to develop automated test methods for software testing.
- Strong analytical, investigative and deductive reasoning skills.
- Strong technical writing skills.
- Knowledge of regression, black box, white box, boundary condition, performance, and other standard testing strategies.
- Self-directed learning.
- Experience in an FDA-regulated environment highly preferred, ideally in medical device.