Software Design Quality Engineer

Mass Digital Health; Massachusetts; On-site; USD 102,000 - 164,000; Full time

Job summary

Philips is hiring a Software Design Quality Engineer in Bedford, MA for an on-site, full-time role. You will lead software design assessment, verification, and validation activities to ensure safety, quality and regulatory compliance throughout the lifecycle.

You will drive risk management (ISO 14971), traceability, cyber security risk management, and post-market analytics. A bachelor’s degree and strong communication skills are required; salary ranges reflect market at Bedford, MA.

Qualifications

• Minimum 5+ years in FDA regulated, IEC 62304 medical device software environments.
• Detailed knowledge of ISO 14971 Risk Management.
• Strong understanding of SDLC and QMS for Software Design Controls.
• Experience with software design assurance, testing, and validation.

Responsibilities

• Lead assessment of software designs using test and performance data to uphold quality, safety, and regulatory standards.
• Oversee software design verification, validation, risk management, traceability, and cyber security risk management.
• Track and assess software anomalies for pre- and post-market medical device software.
• Conduct root cause analyses for quality issues and validate usability, reliability, and performance.
• Author and execute software test protocols and generate test reports.
• Implement quality plans and risk management activities; monitor performance with post-market analytics.
• Oversee regulatory planning and submissions for global registrations for market access.
• Drive regulatory excellence and continuous improvement of processes and efficiency.

Skills

FDA regulated

Software Design Assurance

Risk Management

SDLC

QMS for Software Design

Root Cause Analysis

Software V&V

Agile/SAFe

C/C++/C#

Communication skills

Education

Bachelor’s Degree in Quality/CS/Engineering

ISTQB certification

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. 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.