Systems Verification Engineer
In this role, you have the opportunity to:
Be a part of Philips HRC Systems Engineering group as a Systems Verification and Validation (V&V) Engineer focused on ventilation, gas sensing, and capnography & related accessory products. You will be responsible for assessing and testing the internal requirements and producing clear and concise V&V documents (e.g., plans, protocols, and report) for patient interfacing devices. Additional responsibilities of assessing and testing materials and/or medical devices for compliance to International Standards and FDA Guidance. The position within the System Engineering group collaborates closely with Mechanical Engineers, Electrical Engineers, Optical Engineers, Clinical Affairs, Marketing, and Quality & Regulatory in the business within and outside HRC to develop, commercialize and sustain Class 2 or 3 medical devices.
You are responsible for:
- Formulate and execute on V&V test plans, protocols, and reports.
- Own test equipment and environment knowledge
- Learn from and adhere to the internal quality system.
- Establish effective work processes and standardized procedures that ensure compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with test laboratories.
- Manage and maintain vendors including supporting audits of the contract facilities.
- Author and review V&V adoptions into existing cycles.
- Lead testing and maintain documentation to support the facility of single-use and reusable products.
- Conduct statistical analysis and justifying test results associated with design changes.
- Encourage continuous process improvements environment.
- Additional responsibilities may be assigned, as required, by management.
To succeed in this role, you should have the following skills and experience:
- BS at a minimum. Master’s Degree in an engineering discipline; mechanical engineering, materials science, or equivalent background preferred.
- At least 3+ years’ of experience in verification and validation in a medical device setting.
- In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance.
- In-depth knowledge of medical device regulations and standards – example 18562 and 10993 standards.
- Understanding capnography or gas sensing is a plus.
- Ability to work with teammates in accordance with company objectives.
- Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
- Partner with Quality to support the development, maintenance, and adherence to quality systems and continuous process improvement.
- Partner with research, product development and regulatory affairs functions to ensure new and sustaining products meet all necessary requirements.
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 page on 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.
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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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