WHAT WILL YOU DO?

Under general managerial supervision/oversight, works with development teams in the following areas:

Design Control and Risk Management

• Work with application developers and product teams to support the development of medical devices with software.
• Support the development and qualification of software development tools and services
• Assist in the review of the software test cases and test runs in support of design verification / validation activities
• Review Software Design Documentation
• Support in risk management activities for effective product development and operational activities ensuring compliance with ISO 14971, IEC 62304, ANSI/AAMI SW96.
• Support changes to product designs.

Quality System

• Assist in engineering change order preparation/review
• Assist in quality system procedures periodic review
• Assist QE CAPA owners on CAPA task follow up.
• Assess and improve quality system processes through data monitoring and trend analysis.
• May participate in internal audits, conducting audits.

OTHER DUTIES AS ASSIGNED

Additional other duties and projects as required to facilitate R&D, Operations, Production, Engineering, Clinical and Regulatory goals and objectives.