Colorado Springs, CO
Effective Wednesday, December 8, 2021, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.
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.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
In this role, you have the opportunity to
Support Product Development and Sustaining projects within Image Guide Therapy with respect to software, firmware, and hardware from a quality assurance perspective.
The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
You are responsible for
- Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
- Validate key design inputs like: usability, reliability, performance, supportability, manufacturability, localization, safety, security, privacy, serviceability, sustainability and costs
- Provide effective oversight and is hands-on on the execution of the Quality Plan , any Risk Management activities, and of all design related activities during the, product/system lifecycle
- Perform independent technical assessment on product quality performance and post-market product quality analysis
- Responsible for leading quality related problem solving and root cause analysis during design and manufacturing
- Provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.
- Use post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
- Act as a single point of contact (person assigned to project team) responsible to ensure that design meets quality and compliance standards for every milestone
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you’ll need a customer-first attitude and the following
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Engineering or related Science degree.
- 1+ years of quality engineering or medical devices experience
- ASQ-CQE preferred.
- Graduate degree in Engineering/Science preferred.
- Expertise in applying ISO 13485, ISO 14971, IEC 60601 and working knowledge with IEC 62304 and other relevant medical device standards.
- Knowledge in manufacturing processes
- Experience with medical device development lifecycle mythologies including Agile and SAFe preferred.
- Familiar with systems engineering tools including software tools such as, design traceability, defect tracking and management tools such a Jira or Clearquest.
- Statistical software solutions such as JMP or Minitab
- Design for reliability concepts and relating complaint history to reliability goals on new projects
- Strong leadership skills and ability to work in a team environment
- Highly motivated hands-on engineer/scientist with a proven record of meeting timelines and goals
- Must possess strong analytical & problem-solving skills
- Knowledge of Non-Product Software Validation, IQ OQ PQ
How we work at Philips
Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.
We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some 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.
Equal Opportunity Employer/Disabled/Veteran
Philips maintains a drug-free workplace