Software Design Quality Engineer

Philips; Bedford (MA); On-site; USD 102,480 - 163,968; Full time

Job summary

A global technology company in Bedford, MA is seeking a Software Design Quality Engineer responsible for developing and managing software quality documentation, ensuring accuracy and compliance throughout the software lifecycle. The ideal candidate will have over 5 years of experience in FDA regulated environments, a strong background in risk management and software validation, and excellent communication skills. This position requires working onsite and may involve occasional travel.

Qualifications

• 5+ years’ experience in FDA regulated, IEC 62304 medical device software.
• Strong understanding of Software Design Assurance and Controls.
• Proven experience with complex medical systems and design quality tools.

Responsibilities

• Leads assessment of software designs and quality standards.
• Conducts root cause analyses for software quality issues.
• Implements software quality plans and regulatory compliance.

Skills

FDA regulated experience

Risk Management (ISO 14971)

Root Cause Analysis

Software V&V

Agile and SAFe methodologies

C/C++/C# programming

Communication skills

Education

Bachelor’s Degree in Quality, Computer Science/Engineering or similar

Job description

Job Description

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.
• 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.

Qualifications

• You have a minimum of 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on 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.

Work Location & Requirements

This is an on‑site role requiring full‑time presence in the company's facilities (5 days per week). For our office‑based teams, this means working in‑person at least 3 days per week. You must reside in or within commuting distance to Bedford, MA. The position may require up to 10% travel.

Salary

The pay range for this position in Bedford, MA is $102,480 to $163,968.

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. Must reside in or within commuting distance to Bedford, MA.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.