Software Design Quality Engineer

Philips International; Bedford (MA); On-site; USD 102,000 - 164,000; Full time

Benefits offered by this job

PTO and vacation

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Annual incentive bonus

Sales commission

Long-term incentives

Job summary

Philips is seeking a Software Design Quality Engineer to lead the assessment of medical device software designs, ensuring quality, safety, and regulatory compliance across the lifecycle.

You will drive software V&V, risk management (ISO 14971), traceability, and cybersecurity risk practices, while supporting SDLC processes and regulatory filings for global market access. Remote work is not indicated; this is an on-site role in Bedford, MA.

Qualifications

• Minimum 5+ years in FDA-regulated, IEC 62304 medical device software environments.
• Strong knowledge of ISO 14971 risk management and software design controls.
• Experience with software design assurance/control and SDLC in a regulated setting.
• Ability to interpret software requirements and verify implementation through reviews and testing.

Responsibilities

• Lead assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards.
• Develop and manage software quality documentation and regulatory filings for global registrations.
• Oversee software design verification/validation, risk management, traceability, and cyber security risk management.

Skills

Quality assurance

Regulatory compliance

Risk management

Root cause analysis

Software V&V

Traceability

Regulatory knowledge

C/C++/C#

Agile SAFe

Education

Bachelor’s degree in Quality/CS/Engineering

Tools

ISTQB

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 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. 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.

• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase plan
• education reimbursement and much more
• annual incentive bonus
• sales commission
• long-term incentives

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. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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