DESCRIPTION: Conduct Design V&V activities as an active member of project teams designing and developing medical device software. Software applications are developed for the web and/or client/server platforms.

OUTCOMES: The successful candidate will be responsible for analyzing and verifying product requirements and designs and testing the products at various levels to ensure that the products meet the requirements and intended use.

Tasks include:

• Analyzing product and sub-system requirements.
• Analyzing and verifying medical device designs.
• Writing detailed test procedures that evaluate medical devices and systems against documented software requirements. Includes black box, exploratory, and white box testing.
• Executing test procedures on a web or client/Server platform.
• Maintaining and controlling test execution records using good documentation practices.
• Technical writing, including development of test reports.

BEHAVIORS: The successful candidate will demonstrate the ability to work as a member of a team, solve problems, meet commitments, and ensure quality.

• Works with system level, multi-disciplined engineering projects.
• Requires limited direction.
• Makes risk-based decisions, balancing business and compliance issues.
• Communicates at all levels of the organization.

GROWTH: The successful candidate will develop relationships with teams and may take on activities to plan, guide, and track project efforts.

EDUCATION: BS in Engineering, Computer, or other Science discipline, or equivalent with 2+ years of job related experience. Or Associates Degree with 4+ years of job-related experience.

EXPERIENCE: 2+ years with BS or MS, 4+ years with Associates.

PREFERRED EXPERIENCE:

• Disciplined, regulated industries, medical device experience preferred, including FDAs 21 CFR 820/ISO 13485 experience.
• Software development using ISO 62304 or equivalent.
• Risk Management using IEC 14971 and IEC 60601 or equivalent.

ADDITIONAL EXPERIENCE DESIRED:

• Familiarity with QTP and/or UFT.

OTHER REQUIREMENTS: Physical Requirements: Sedentary desk/office job with frequent lifting of up to 10 pounds; requires physical skills to operate computer and other mechanical/electrical equipment