Software Design Assurance Quality Engineer

About the role

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.

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.
• Safeguards 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.
• Maintains 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.
• Identifies and supports processes and design quality tools for use in tracking/preventing software defects, design traceability, and Design for Quality (DfQ).
• Shares knowledge, insights regarding software quality standards, and regulatory requirements.
• Advocates for and implements best practices, tools, and innovative methodologies to enhance software quality and regulatory compliance.

  Requirements

  • A 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).
  • 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.
  • Ability 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.
  • Agile/SAFe certifications desired.

  Qualifications

  • Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

  Skills

  • Working knowledge of relevant global regulations, requirements, and standards.
  • Experience with cloud-based medical software- SaMD, Health IT, or Electronic Medical Records EMR.
  • AI Large Language Model (LLM) experience is also desired.
  • Experience with IEC 62304/82304, Software Design Assurance/Controls or development, Software Risk Management (ISO 14971), SDLC, and Agile.
  • Experience with cloud-based medical software- SaMD, Health IT, or Electronic Medical Records EMR.
  • Experience with AI Large Language Models (LLMs).

  Benefits

  • Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

  Pay

  The pay range for this position in Cambridge, MA is $102,000 to $163,000. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

  Schedule

  This is an Office role. May require travel up to 10%.

  Contact

  If you are interested in this position, please apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.