Senior Systems Test/V&V Engineer
In this role, you have the opportunity to:
Be a part of Philips Hospital Respiratory Care (HRC) Verification and Validation group as a Senior Systems V&V Engineer focused on Ventilators & related accessory products.
You are responsible for:
- Design, documentation, and execution of controls and performance test procedures for ventilator products in conjunction with product development.
- Close collaboration with other R&D functions (controls, mechanical, electrical, software, systems), Marketing, Clinical Affairs, and Quality & Regulatory.
- Write, update and execute manual and automated test procedures for medical devices
- Analyze test protocols to ensure that test coverage of requirements is complete and correct
- Work with cross functional teams to analyze test failures and determine root cause
- Maintain tools and equipment used by the development and test teams
- Coordinate the return of equipment to the Calibration department for periodic maintenance
- Review and assess the impact of equipment that fails calibration, and documenting calibration requirements for newly acquired equipment
- Follow applicable Quality System procedures for all assigned tasks
- Participate in project teams in NPI, failure investigations, sustaining engineering, etc.
- Communicate ideas and issues effectively to other team members and management.
- Prepare V&V documents, technical reports, and presentations, as required.
- Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR).
You are a part of:
As part of a talented engineering team, the Senior Systems Test/V&V Engineer will drive the systems test/V&V elements of R&D projects to ensure we meet product level requirements.
To succeed in this role, you should have the following skills and experience:
- Minimum of Bachelor’s or Master’s degree in Engineering or equivalent discipline
- 5+ years of system testing, Integration, test automation or related experience
- 5+ years’ experience in medical device or other regulated industry (DOD/Aerospace etc..)
- Strong written/verbal communications skills and attention to detail
- Design verification test development, execution, report generation.
- Knowledge of product development process and design control from concept to volume production.
- Knowledge of quality assurance techniques/practices and Medical Device Regulations/compliance: IEC 62304, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR, etc.
- Understanding of ventilator and gas sensing products, applications, and technologies a plus.
- Six Sigma (DFSS) Green Belt certification with actual project experience a plus
- Knowledge of Data Acquisition and Simulation tools (VisSim, Matlab, LabView, etc)
- Test automation with Hardware interfaces
- Experience with sample size determination and design of experiments
- Verification & validation plans, protocols, and reports.
- Project plans, project schedules, risk / benefit / cost analysis.
- Design control, quality system, risk management, dFMEA, PDP, CAPA.
- Software design process from concept to architecture to production.
- System development process – concept, system bring up and debug.
- This position may require domestic or international travels up to 20% of the time.
- Leadership: The ability to make things happen by encouraging and channeling the contributions of others, recognizing and addressing important issues in a timely manner, and acting as an agent for change and continual improvement when required to achieve results.
- Accountability/Ownership: Work closely with team members and take ownership and deliver fast – educate and communicate to the team.
- Influence: The demonstrated ability to gain acceptance and commitment from other to one’s own beliefs and ideas.
- Negotiating: The ability to construct and maintain a strong bargaining position so as to ensure positive response and agreement: striving for win-win situations.
- Adaptability: Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
- Data-Driven Decision Making: the ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
In return, we offer you:
An exciting opportunity to be part of an innovative, multidisciplinary team with diverse backgrounds and expertise. Philips is a leading innovator in the field of Hospital Respiratory Care…
Why should you join Philips?
Working at Philips is more than a job. It is 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 is 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.
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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