Philips Sr. Software Quality Engineer in United States of America - Home Based, Massachusetts
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Provide leadership and is responsible and accountable to provide oversight throughout the software quality lifecycle as we move toward software based devices.
You are responsible for
Oversight of quality and risk management throughout the software lifecycle, independently audits the adequacy of design specifications, Verification &Validation test plans, and reliability test plans for products.
Participate with cross-functional team with other business and engineering disciplines.
Establish the principles of product and service quality evaluation and control for the system.
Provide independent oversight and review of the project deliverables throughout the product lifecycle.
Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design.
Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle.
Can lead quality related problem solving for software.
Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions when required.
Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards for every PRP milestone.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree required in a technical discipline.
Working knowledge of appropriate global medical device regulations, requirements, and standards for Software in medical devices.
At least 5 years of related experience in a medical device or regulated industry.
Experience with Agile Methodology and different SDLC.
Experience with CI/CD and DevOps tools such as: configuration management, source control, unit testing, etc.
Able to work effectively with minimal supervision
Proficient knowledge of domestic and international standards
Strong background in Design Controls.
Experience in supporting international registrations and/or clinical investigations.
Understand LEAN concepts, methodologies and deployment.
May require 5% travel annually with possibly some international.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips pageon our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.
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