Software Design Quality Engineer

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

Benefits offered by this job

Generous PTO

401(k) up to 7% match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Mass Digital Health is looking for a Software Design Quality Engineer located in Bedford, MA. You will be responsible for developing and managing comprehensive software quality documentation, ensuring regulatory compliance throughout the software lifecycle. The ideal candidate should have over 5 years of experience in FDA regulated environments and possess a Bachelor's Degree in a related field. This full-time, on-site position offers a competitive salary range of $102,480 to $163,968 plus comprehensive benefits.

Qualifications

• Minimum of 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments.
• Proven experience in Root Cause Analysis and Software V&V.
• Strong experience with complex medical systems containing software, hardware and disposables.

Responsibilities

• Leads the assessment of software designs by reviewing test and performance data.
• Conduct detailed root cause analyses for software quality issues.
• Implement software quality plans and risk management activities, monitor performance, initiate corrective actions.

Skills

FDA regulated software environments

Root Cause Analysis

Software V&V

Risk Management

Agile methodologies

Education

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

Job description

Software Design Quality Engineer

Job Description

Software Design Quality Engineer 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 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 validate key design inputs such as 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, utilize 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 optimizing regulatory processes for efficiency while maintaining high compliance standards.

Qualifications:

• 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.
• 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.
• Ability to share knowledge, insights regarding software quality standards, and regulatory requirements.
• 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.
• Minimum of a Bachelor’s Degree (Required) in Quality, Computer Science/Engineering or similar disciplines. ISTQB certification desired.
• Must be able to successfully perform the following minimum physical, cognitive and environmental job requirements with or without accommodation for this position.

Work Location & Requirements:

• Work is office-based; must be onsite at least 3 days per week with full‑time presence (5 days per week) required.
• Field roles typically performed outside of company facilities; this position is an onsite role.
• 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. You must reside in or within commuting distance to Bedford, MA.
• May require travel up to 10%.

Benefits & Compensation:

• Pay range in Bedford, MA: $102,480 to $163,968. Actual base pay may vary within the posted range based on factors including experience.
• Additional compensation such as annual incentive bonus, sales commission or long‑term incentives may be offered.
• Employees eligible for comprehensive benefits program including generous PTO, 401(k) up to 7% match, HSA with company contribution, stock purchase plan, education reimbursement, and more.

Legal Information:

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