Koninklijke Philips N.V - Pittsburgh, PA
posted 6 months ago
About the position
The Systems Integration Engineer will play a critical role as a part of the Sleep and Respiratory Care R&D/Systems Engineering Team that is responsible for developing and sustaining respiratory ventilators and sleep therapy devices, ensuring our Sleep & Respiratory Care (S&RC) products are safe, reliable, and of the highest quality. This position involves supporting Lead Systems Engineers with the overall Systems Engineering deliverables and activities, which include translating user and business requirements into product requirements, developing technical approaches and system architectures, and harmonizing system designs across relevant products and projects. The engineer will also be responsible for assessing the feasibility of potential technical solutions and allocating derived requirements to subsystems using appropriate statistical techniques. In addition, the Systems Integration Engineer will develop system integration plans that define the order in which lower-level components and sub-assemblies are integrated and tested into a fully functional system. This role includes owning system-level defect analysis and remediation during the System Integration, Verification, and Validation phases, leading root cause analysis for high-priority field issues, and planning and executing system-level design reviews. The engineer will also develop and refactor algorithms for system control, alarm generation, and enhancing overall system functionality, as well as lead efforts to design testing methodologies for accurately measuring critical performance parameters. Reporting to the Sr. Manager of Systems Integration, the engineer will collaborate with a cross-functional team of engineers and specialists throughout the Sleep & Respiratory Care organization. This is a hybrid role based in Pittsburgh, PA, which may require travel up to 10%.
Responsibilities
- Support Lead Systems Engineers with overall Systems Engineering deliverables and activities.
- Translate user and business requirements to product requirements.
- Develop technical approaches and system architecture.
- Harmonize system design among relevant products and projects.
- Allocate derived requirements to subsystems.
- Assess feasibility of potential technical solutions.
- Develop system integration plans for component integration and testing.
- Own system-level defect analysis and remediation during System Integration, Verification, and Validation phases.
- Lead root cause analysis for high-priority field issues.
- Plan and execute system-level design reviews.
- Develop and refactor algorithms for system control and alarm generation.
- Lead efforts to design testing methodologies for measuring critical performance parameters.
Requirements
- Minimum of 3 years' experience in developing complex, highly regulated products/systems, preferably FDA regulated medical devices.
- Experience in systems engineering and integration (hardware, software, consumables).
- Strong understanding of the System Design process, including Model-Based/V-Model Design approach.
- Experience in test-driven development methodologies.
- Analytical and architectural thinking skills.
- Experience in developing and optimizing algorithms using machine learning techniques.
- Effective communication, documentation, presentation, and interpersonal skills.
- Strong knowledge of Medical Device/FDA Quality System Regulations (ISO 13485/14971/10993/18562, 17510 2015, IEC 62366).
- Bachelor's Degree in Engineering (Systems, Biomedical, Mechanical or similar discipline) required; Master's degree preferred.
Nice-to-haves
- Experience in Sleep Therapy/Ventilation products/accessories.
- Demonstrated focus on Patient Safety and Quality as an organizational value.
Benefits
- Health insurance coverage
- Dental insurance coverage
- 401k retirement savings plan
- Flexible scheduling options
- Paid holidays and vacation time
- Professional development opportunities
- Employee discounts on products and services
