Software Design Assurance Eng

Philips•Bedford, MA

9d•$102,480 - $163,968•Onsite

About The Position

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. Your role: Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies. Lead 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. Track and risk assess software Anomalies for pre- and post-market medical device software. Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance. Assess 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. Ensure 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. Drive 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.
Ability 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.
Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements.
Minimum of a Bachelor’s Degree (Required), in Quality, Computer Science/Engineering or similar disciplines.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Must reside in or within commuting distance to Bedford, MA.

Nice To Haves

ISTQB certification desired.

Responsibilities

Develops, maintains, and manages comprehensive software quality documentation.
Ensures accuracy and regulatory compliance of software quality documentation throughout the software lifecycle.
Leads the assessment of software designs by reviewing test and performance data.
Upholds quality, safety, and regulatory standards.
Addresses engineering deficiencies.
Leads in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation.
Tracks and risk assesses software Anomalies for pre- and post-market medical device software.
Conducts detailed root cause analyses for software quality issues.
Validates key design inputs like usability, reliability, and performance.
Assesses products and systems to identify defects, abnormalities and design flaws.
Authors and executes software test protocols and generates test reports.
Implements software quality plans and risk management activities.
Utilizes post-market analytics to monitor software performance.
Initiates corrective actions as needed.
Ensures compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes.
Manages 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.