Software Design Assurance Quality Engineer

Job Title

Software Design Assurance Quality Engineer

Job Description

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.

Your role :

* 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.

You're the right fit if:

* You have 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.

* You have experience with cloud-based medical software
- SaMD, Health IT, or Electronic Medical Records EMR. AI Large Language Model (LLM) experience is also desired.

* You have proven experience identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, and Design for Quality (DfQ).

* You're able to share knowledge, insights regarding software quality standards, and regulatory requirements.

* You have a minimum of a Bachelor's Degree (Required), in Quality, Computer Science/Engineering or similar disciplines. Agile/SAFe certifications desired.

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

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

* Learn more about our business.

* Discover our rich and exciting history.

* Learn more about our purpose.

* Learn more about our culture.

Philips Transparency Details:

* The pay range for this position in…