Software Design Assurance Eng

About the role

The Software Design Quality Engineer is responsible for developing, maintaining, and managing comprehensive software quality documentation, ensuring their accuracy and regulatory compliance throughout the software lifecycle.

Responsibilities

• Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies.
• Leads in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation including- Software design/verification, Risk management, Systems validation, Traceability and Cyber security risk management.
• Tracks and risk assesses software anomalies for pre- and post-market medical device software.
• Conducts detailed root cause analyses for software quality issues and validates key design inputs like usability, reliability, and performance.
• Affirms products and systems to identify defects, abnormalities and design flaws by authoring and executing software test protocols and generating test reports.
• Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed.
• Ensures compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access.
• Drives regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards.

Requirements

• Minimum of 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on product-based Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong Understanding of all aspects of the QMS related to Software Design Controls.
• Proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe.
• Strong experience with complex medical systems containing software, hardware and disposables.
• Able to share knowledge, insights regarding software quality standards, and regulatory requirements.
• Excellent written and verbal communication skills, with the ability to communicate and present to all levels of management.
• Able to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.

Qualifications

• Minimum of a Bachelor’s Degree (Required), in Quality, Computer Science/Engineering or similar disciplines.
• ISTQB certification desired.

Skills

• Software Design Assurance/Control
• Risk Management (ISO 14971)
• SDLC
• Quality Management System (QMS)
• Software Verification and Validation (V&V)
• Root Cause Analysis
• Design for Quality (DfQ)
• Agile
• SAFe

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Bedford, MA is $102,480 to $163,968.

Schedule

This is an ON-SITE role. May require travel up to 10%.