Lead the development and authoring of software Verification test plans, protocols, and reports for medical devices. Support a diverse and distributed medical device development team with requirement analysis and test strategies.
- Excellent written and verbal communication skills, including the ability to collect data, concisely organize information and author reports.
- Ability to comprehend detailed software specifications and write corresponding test protocols
- High attention to detail and ability to lead V&V efforts to timely completion
- Able to perform well in a fast-paced, team environment
DUTIES AND RESPONSIBILITIES
- Experience developing/configuring scripting and automation frameworks
- Excellent understanding of software design verification and validation for medical devices.
- Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical ability.
- Working knowledge in SDLC, STLC, test methodologies and defect management
- Working knowledge of ISO 13485, IEC 62304, or IEC 62366, a plus
- Knowledge of software programming and embedded systems, C++, a big plus.
- Successful 510K submissions, a plus
EDUCATION and/or EXPERIENCE
- Develop and execute software/firmware verification protocols for FDA regulated medical devices
- Participate in product requirements analysis to ensure testability
- Develop test plans and strategies to verify design specifications
- Review and support on engineering change requests, deviation notices, and risk management
- Utilize issue tracking tools and other methods to ensure consistent traceability between requirements, the design and test cases
- Minimum of bachelor’s degree or
- Minimum of two (2) years related experience in a regulated software development/test environment.