The Systems Engineer will play a critical role as a part of the Sleep and Respiratory Care R&D/Systems Engineering Team, 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.Your role:
Responsible for the overall Systems Engineering deliverables and activities including translation of user and business requirements to product requirements, technical approach and system architecture development, harmonization of system design among the relevant products and projects of the segment(s), allocation of derived requirements to subsystems, and integration strategy and methods.
Drives refinement and translation of user requirements (including but not limited to clinical, serviceability, reliability, and manufacturability), regulatory requirements, and system architecture and concepts into functional requirements. Manage requirements to be compliant with requirement management policies and ensure coverage, quality, and full implementation of requirements.
Responsible for technical approach, system top-level design, feasibility of potential technical solutions, and allocation of derived requirements (including functionality, interface specifications and design budgets) onto affected subsystems.
Plans and executes system-level design reviews.
Owns system-level defect analysis and remediation during System Integration, Verification and Validation phases.
Support Product Risk Management, regulatory and standard fulfillment and country approval.
Manage technical risk by conducting thorough risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and developing risk control measures.
Reporting to the Director of Systems Engineering, 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 3 years’ experience successfully developing complex medical devices and a focus in systems engineering (hardware, software, consumables), with experience in Sleep Therapy/Ventilation products and accessories highly desired.
You have a strong understanding of the System Design process, including Model-Based/V-Model (Desired) design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation.
You have experience in test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.
You have strong knowledge of Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562 ,17510 2015, IEC 62366 etc.) and clearance processes.
You’ve demonstrated a relentless focus on Patient Safety and Quality as 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 position .
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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 here.#LI-PH1It 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.Equal Employment and Opportunity Employer/Disabled/Veteran
