Software Design Assurance Eng in Bedford

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.
• 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.
• Conduct 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.
• Implement software quality plans and risk management activities, utilise post-market analytics to monitor software performance, and initiate 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 optimising regulatory processes for efficiency while maintaining high compliance standards.

Qualifications

• You have a 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.
• You have 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.
• You’re able to share knowledge, insights regarding software quality standards, and regulatory requirements.
• You have 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.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Computer Science/Engineering or similar disciplines. ISTQB certification 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 apart. 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 ON-SITE 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.

Additional Information

• 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.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.
• May require travel up to 10%.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to 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.