Systems Engineer

Philips•Alvin, TX

1d•Onsite

About The Position

The Systems Engineer is part of Philips’ Sleep and Respiratory Care R&D/Systems Engineering Team, which develops and sustains respiratory ventilators and sleep therapy devices. The role supports the safety, reliability, and quality of Sleep & Respiratory Care products by owning systems engineering deliverables throughout product development and sustainment. The engineer translates user, business, clinical, serviceability, reliability, manufacturability, and regulatory requirements into functional and technical requirements and system architecture. The role develops technical approaches and top-level designs, evaluates feasibility, allocates derived requirements to subsystems, and establishes integration strategies and methods. It also manages requirements for coverage, quality, compliance, and implementation; plans and conducts system-level design reviews; and leads system-level defect analysis and remediation during integration, verification, and validation. The position supports product risk management, regulatory and standards fulfillment, and country approvals. It includes conducting risk analyses such as Design Failure Mode and Effects Analysis (DFMEA) and developing risk controls. This is an office role based in New Kensington, Pennsylvania. Office-based teams work in person at least three days per week; onsite roles require full-time presence at company facilities. Candidates must reside in or within commuting distance of New Kensington, and U.S. work authorization is required without current or future visa sponsorship.

Requirements

At least 2 years of successful experience developing complex medical devices, with a focus in systems engineering across hardware, software, or consumables.
Strong understanding of the system design process, including Model-Based Systems Engineering (MBSE) and the V-Model: conceptualization, requirements writing, functional and technical design, checking and optimization, verification, integration, and validation.
Knowledge of medical device and FDA quality system regulations and standards, including ISO 13485, ISO 14971, ISO 10993, ISO 18562, ISO 17510:2015, and IEC 62366.
Bachelor’s degree in Engineering, preferably Systems, Biomedical, Mechanical, or a similar discipline.
Ability to meet the position’s minimum physical, cognitive, and environmental job requirements, with or without accommodation.
Effective communication, computer, documentation, presentation, and interpersonal skills.
Ability to work independently, cross-functionally, and collaboratively.
Demonstrated focus on patient safety and quality.
U.S. work authorization; candidates requiring work-authorized visa sponsorship now or in the future will not be considered.
Must reside in or within commuting distance of New Kensington, Pennsylvania.

Nice To Haves

Experience with Sleep Therapy or ventilation products and accessories.
Master’s degree.
Experience with test-driven design methodologies.
Analytical and architectural thinking, a systems view, physical insight, flexibility, and a hands-on mentality for delivering sustainable results and creative solutions.

Responsibilities

Own overall Systems Engineering deliverables and activities, including translating user and business requirements into product requirements.
Develop the technical approach and system architecture, harmonize system design across relevant products and projects, allocate derived requirements to subsystems, and define integration strategies and methods.
Refine and translate user requirements, including clinical, serviceability, reliability, and manufacturability needs, as well as regulatory requirements and system architecture concepts, into functional requirements.
Manage requirements in compliance with requirement management policies and ensure their coverage, quality, and full implementation.
Develop the technical approach and system top-level design, assess the feasibility of potential technical solutions, and allocate derived requirements—including functionality, interface specifications, and design budgets—to affected subsystems.
Plan and execute system-level design reviews.
Own system-level defect analysis and remediation during system integration, verification, and validation.
Support Product Risk Management, regulatory and standards fulfillment, and country approval.
Conduct risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and develop risk control measures.