Software Design Assurance Eng

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

Benefits offered by this job

Generous PTO

401(k) plan (up to 7% match)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips Iberica SAU is seeking a Software Design Assurance Engineer in Bedford, MA. This role involves ensuring software quality compliance and overseeing regulatory activities for medical device software. Ideal candidates will have 5+ years of experience in regulated environments, a strong background in Risk Management, and programming skills in object-oriented languages.

The pay range for this position is $102,480 to $163,968, along with benefits such as 401(k) matching, bonus opportunities, and education reimbursement.

Qualifications

• Minimum 5+ years’ experience in FDA-regulated medical device software.
• Detailed knowledge of Risk Management and SDLC.
• Excellent communication skills for all management levels.

Responsibilities

• Lead software design assessments for quality and safety.
• Oversee regulatory compliance for software products.
• Implement software quality plans and risk management activities.

Skills

FDA compliance

Risk Management (ISO 14971)

Root-Cause Analysis

Software Verification & Validation

Agile methodologies

C/C++/C# programming

Education

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

Tools

Quality Management System (QMS)

Job description

Job Title

Software Design Assurance Eng

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.
• Leads the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation, including software design/verification, risk management, system validation, traceability, and cyber‑security risk management.
• Tracks and risk‑assesses software anomalies for pre‑ and post‑market medical device software.
• Conducts detailed root‑cause analyses for software quality issues and validates key design inputs such as usability, reliability, and performance.
• Assesses 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.
• Ensures compliance across the product software lifecycle by overseeing regulatory planning and execution for new products and changes, managing filings and approvals, and overseeing the preparation and submission of documentation for global registrations to enable timely market access.
• Drives 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, focusing 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.
• 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 and 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.

Pay Range

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job‑related knowledge, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission, or long‑term incentives may be offered. Employees are eligible to participate in a comprehensive total‑rewards benefits program, which includes generous PTO, a 401(k) plan (up to 7% match), HSA (with company contribution), a stock purchase plan, education reimbursement, and much more.

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%.

EEO statement

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