Sleep Systems Engineer

2 weeks ago


Pittsburgh, Pennsylvania, United States Philips North America Full time

Position Title: Sleep Systems Engineer

Overview: The Sleep Systems Engineer will be an integral member of the Sleep and Respiratory Care Research & Development/System Engineering Team, dedicated to the innovation and maintenance of respiratory ventilators and sleep therapy solutions. This role is pivotal in ensuring that our Sleep & Respiratory Care (S&RC) offerings meet the highest standards of safety, reliability, and quality.

Your Responsibilities:

  • Lead the overall Systems Engineering outputs and tasks, including the conversion of user and business needs into product specifications, technical strategies, and system architecture development.
  • Facilitate the refinement and transformation of user requirements (encompassing clinical, serviceability, reliability, and manufacturability), regulatory guidelines, and system concepts into actionable functional requirements. Ensure compliance with requirement management protocols, guaranteeing comprehensive coverage and quality of requirements.
  • Oversee the technical strategy, top-level system design, feasibility assessments of potential technical solutions, and the distribution of derived requirements (including functionality, interface specifications, and design constraints) across relevant subsystems.
  • Organize and conduct system-level design evaluations.
  • Manage system-level defect identification and resolution during the System Integration, Verification, and Validation phases.
  • Support Product Risk Management, adherence to regulatory standards, and approval processes.
  • Mitigate technical risks through comprehensive risk assessments, including Design Failure Mode and Effects Analysis (DFMEA), and the formulation of risk control strategies.
  • Reporting to the Director of Systems Engineering, collaborate with a diverse team of engineers and specialists across the Sleep & Respiratory Care division.
  • Work Environment: This position is hybrid, based in Pittsburgh, PA, and may involve occasional travel.

Qualifications:

  • A minimum of 1 year of experience in the development of complex medical devices, with a focus on systems engineering (hardware, software, consumables), particularly in Sleep Therapy/Ventilation products and accessories.
  • Strong comprehension of the System Design process, including Model-Based Systems Engineering (MBSE/V-Model) methodologies, from conceptualization to validation.
  • Experience with test-driven design practices, analytical and architectural reasoning, and a hands-on approach to achieving sustainable results and innovative solutions.
  • Excellent communication, documentation, presentation, and interpersonal skills, with the ability to work independently and collaboratively across functions.
  • In-depth knowledge of Medical Device/FDA Quality System Regulations (ISO 13485/14971/10993/18562, IEC 62366, etc.) and regulatory approval processes.
  • A demonstrated commitment to Patient Safety and Quality as core organizational values.
  • A Bachelor's Degree in Engineering (Systems, Biomedical, or a related field) is required; a Master's degree is preferred.
  • Ability to meet the minimum physical, cognitive, and environmental job requirements with or without accommodation.
  • Must possess US work authorization; sponsorship for work visas is not available.
  • Relocation benefits are not offered for this position; candidates must reside in or near Pittsburgh, PA.

About Philips North America:

Philips is a health technology organization committed to the belief that every individual matters. We strive to ensure that everyone has access to quality healthcare. Join us in making a difference in the lives of others.

  • Explore our business.
  • Discover our rich history.
  • Learn about our mission.
  • Review our employee benefits.

If you are interested in this role and possess many of the required experiences, we encourage you to apply. You may be the ideal candidate for this or other opportunities at Philips.

Philips is an Equal Employment Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.



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