Philips Systems Engineer-Patient Interface 

United States, Pennsylvania 

961151462

Systems Engineer-Patient InterfaceJob Description

The Systems Engineer will play a critical role as a part of the Patient Interface (Masks) R&D Engineering Team, responsible for developing and evaluating sleep/ventilation therapy masks and wearables, as well as providing a superior level of technical/product support, ensuring our Sleep & Respiratory Care (S&RC) products are safe, reliable and of the highest quality.

Your role:

• Incorporates essential operating mechanisms of systems engineering of medical device design and engineering principles and adheres to medical device regulations.
• Defines User Requirements, system requirements, FMEA, architecture, and interfaces to meet product requirements, risk analysis and industry standards; conducts system design analysis to select key components and defines control methods; and coordinates build and design integration.
• Works together to support product verification and validation planning, resolution of technical integration issues, safety agency interface, system testing and coordination.
• Conducts design reviews as part of the product development process to ensure customer requirements are met and the designs are manufacture-able, serviceable, and reliable. In addition, it does the same for subsystem requirements and product integration.
• Leadership:Drive critical initiatives by encouraging and channeling the contributions of others; recognizing and addressing critical issues in a timely manner and acting as an agent for change and continual improvement when required to achieve results. Leads or contributes to setting technical direction and establishes a standard of work for the team.
• Working in Ambiguity:Take underdefined/complex issues and set direction to resolve them in an aligned manner with stakeholders.
• Adaptability:Must be able 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: Move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
• Reporting to the Manager of Core Research & Advanced Development, you will collaborate with a cross functional team of engineers and specialists throughout the Sleep & Respiratory Care organization.
• This Hybrid
  , Pittsburgh, PA based role, may require travel up to 10%.

You're the right fit if:

• You’ve acquired a minimum of 5 years’ experience successfully developing complex medical devices (hardware, software, consumables) and a focus in systems engineering-V-model, starting with conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally thevalidation. Experiencein Sleep Therapy/Ventilation products and accessories highly desired.
• You have a strong understanding of System Design process, including Model-Based (MBSE) Design approach, Test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creativesolutions.
• You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, andcollaboratively.
• You have strong knowledge of Medical Device/ FDA Quality System Regulations (ISO13485/14971/10993/18562,17510 2015, IEC 62366 etc.) and clearance processes.
• You’ve demonstrated arelentless focus on Patient Safety and Qualityas an organizational value.
• You have a minimum of a Bachelor’s Degree in Engineering- Systems, Biomedical, Mechanical or similar discipline (required), Master’s degree (preferred).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this.
• 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.

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.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.