Software Design Assurance Quality Engineer

Philips•Cambridge, MA

2d•$102,000 - $163,000•Hybrid

About The Position

The Software Design Assurance Quality Engineer is responsible for ensuring top-level design quality assurance for the creation, modification, maintenance of cloud based medical software used to provide medical monitoring, ensuring software accuracy and regulatory compliance throughout the software lifecycle for Philips Ambulatory Monitoring & Diagnostics products.

Requirements

Minimum of 3+ years’ experience in FDA regulated medical device/Tech software environments, (IEC 62304/82304), with a focus on Software Design Assurance/Controls or development, Software Risk Management (ISO 14971), SDLC, and Agile.
Experience working in an ISO 9007 environment is beneficial.
Experience with cloud-based medical software- SaMD, Health IT, or Electronic Medical Records EMR.
Proven experience identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, and Design for Quality (DfQ).
Able to share knowledge, insights regarding software quality standards, and regulatory 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 Cambridge, MA.

Nice To Haves

AI Large Language Model (LLM) experience is also desired.
Agile/SAFe certifications desired.

Responsibilities

Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any software engineering deficiencies.
Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance.
Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective/field actions corrective when required to maintain software quality.
Ensures the development of comprehensive Software Quality Plans that cover all stages of the software lifecycle, from design through to post-market, supporting the design of these plans and ensuring adherence to quality and regulatory standards.
Applies working knowledge of relevant global regulations, requirements, and standards, ensuring that all software quality activities/design processes comply with applicable regulatory requirements, facilitating compliance throughout the software development lifecycle.
Provides guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes.
Monitors, and reports on key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders.
Help to identify opportunities for process improvements within software quality engineering, advocating for and implementing best practices, tools, and innovative methodologies to enhance software quality and regulatory compliance.