Senior Design Assurance Engineer I

GLAUKOS - SR. DESIGN ASSURANCE ENGINEER (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.

How will you get here?

• Bachelor's degree required.
• ASQ CSQE certification preferred.
• 5+ years of medical device or experience in a semi-regulated industry is required, 8+ years preferred
• Strong knowledge of medical device manufacturing and software development
• In-depth knowledge of GMP, ISO 13845, ISO 14971, EU MDD/MDR, GDPR - General Data Protection Regulation, and 21 CFR Part 820 FDA requirements, ISO 62304 and IEC 60601 software requirements.
• Expertise in medical product quality assurance (including the requirements for test protocols and statistical techniques).
• Proficiency in various programming languages, such as C++, CSharp, or Python, and experience with software development tools, such as version control systems, bug tracking systems, and automated testing tools.
• Excellent documentation skills, attention to detail and accuracy
• Team player, good written/oral communicator
• Must be organized and able to coordinate activities with internal departments and outside vendors
• Establishes reputation as an emerging leader internally with sustained performance and accomplishments
• Demonstrates strategic thinking and commercial/industry understanding in functional projects
• Proficient data entry and typing skills
• ERP systems experience required

#GKOSUS