Software Design Quality Engineer

Regulatory Toolkit; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Job summary

Philips in Bedford, MA is seeking a Software Design Quality Engineer to ensure regulatory compliance and robust software quality throughout the lifecycle. You will lead design reviews, risk management, verification activities, and testing protocols for medical device software in FDA/IEC 62304 environments.

You will perform root cause analysis, support regulatory filings, and drive continuous improvement in software design controls, traceability, and quality assurance across hardware and software

Qualifications

• 5+ years’ experience in FDA regulated, IEC 62304 medical device software environments with focus on Software Design Assurance/Control.
• Strong knowledge of Risk Management (ISO 14971), SDLC and QMS related to Software Design Controls.
• Experience in Root Cause Analysis, Software V&V, defects tracking, design traceability, Design for Quality (DfQ), Agile, SAFe.
• Experience with complex medical systems containing software, hardware and disposables.
• Ability to communicate regulatory requirements and software quality standards effectively.
• Excellent written and verbal communication skills for all management levels.
• Bachelor’s degree required; ISTQB certification desired.
• Must meet physical, cognitive and environmental job requirements.

Responsibilities

• Lead assessment of software designs by reviewing test data to uphold quality, safety, and regulatory standards.
• Apply and improve policies related to software development and validation including design verification, risk management, and systems validation.
• Track and risk assess software anomalies for pre- and post-market medical device software.
• Conduct root cause analyses for software quality issues and validate key design inputs such as usability and performance.
• Assess products to identify defects by authoring/executing test protocols and generating reports.
• Implement software quality plans and risk management activities; monitor performance with post-market analytics.
• Ensure lifecycle regulatory planning and execution for new products/changes; manage filings and approvals for global registrations.
• Drive regulatory excellence and continuous improvement by developing plans and optimizing processes.

Skills

Software quality

Regulatory compliance

Root Cause Analysis

Software Design Assurance

SDLC

Communication

Education

Bachelor’s degree

ISTQB certification desired

Tools

C/C++/C#

Job description

Job Title

Software Design Quality Engineer

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.

Your role:

• 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.

You're the right fit if:

• 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 a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) 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-based 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 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/skills, experience, business needs, geographical location, and internal equity.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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 our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

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%.

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