GLAUKOS – SR. DESIGN ASSURANCE ENGINEER, SOFTWARE (R&D QUALITY, SOFTWARE) BURLINGTON, MA

How will you make an impact?
The Senior Design Assurance Engineer I, with concentration on Software subsystems will support the Quality Engineering (QE) staff to ensure all software development activities are compliant with required regulations and standards under Design Control and maintained throughout the product lifecycle of innovative ocular medical devices.
Responsibilities include reviewing design control deliverables, creating and updating risk management files pertaining to software and product security, maintaining the Design History File compliance and supporting assessment/implementation of design changes to already approved medical devices. This role will support the development of new product software designs as well as the maintenance and enhancements of existing products from the software perspective.

WHAT WILL YOU DO?

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

Design Control and Risk Management

• Ensure software product development meets required regulations and standards.
• Support risk management activities to ensure compliance with ISO 14971, IEC 62304, ANSI/AAMI SW96.
• Review software design documentation including requirements, V&V plans, protocols and reports
• Organizing data for product development and analysis. This includes work in requirements trace matrix tools (ALM) and Static Analysis tools.
• Support changes to product designs.
• Support the development and qualification of software development tools and services
• Support changes to software product designs.

Quality System

• Assist in engineering change order preparation/review
• Assist in quality system procedures periodic review and updates
• 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.