Systems Engineer

Philips • New Kensington, PA

13d • $102,000 - $163,000 • 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 contributes to ensuring these products are safe, reliable, and of high quality.

The position owns overall systems engineering deliverables, including translating user and business needs into product requirements, developing technical approaches and system architectures, coordinating system design across relevant products and projects, allocating derived requirements to subsystems, and defining integration strategies and methods. It also translates clinical, serviceability, reliability, manufacturability, regulatory, and other needs into functional requirements, while ensuring requirements meet management policies and are complete, high quality, and fully implemented.

The Systems Engineer is responsible for system-level design, assessing technical feasibility, allocating functional and interface requirements and design budgets to affected subsystems, and planning and executing system-level design reviews. The role also leads system-level defect analysis and remediation during integration, verification, and validation; supports product risk management, regulatory and standards compliance, and country approvals; and conducts risk analyses such as DFMEA to develop 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 US work authorization is required without current or future sponsorship. Relocation benefits are not provided.

Requirements

• At least 2 years of successful experience developing complex medical devices, with a focus in systems engineering across hardware, software, or consumables.
• Bachelor’s degree in Engineering; Systems, Biomedical, Mechanical, or a similar discipline is preferred.
• Strong understanding of the system design process, including model-based systems engineering or V-Model design: 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, as well as clearance processes.
• Effective communication, computer, documentation, presentation, and interpersonal skills.
• Ability to work independently, cross-functionally, and collaboratively.
• Demonstrated focus on patient safety and quality.
• Ability to successfully perform the stated minimum physical, cognitive, and environmental job requirements, with or without accommodation.
• US work authorization, with no need for sponsorship now or in the future.
• 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 approach to delivering sustainable results and creative solutions.

Responsibilities

• Own overall systems engineering deliverables and activities, including translating user and business requirements into product requirements.
• Develop technical approaches and system architectures, harmonize system design across relevant products and projects, allocate derived requirements to subsystems, and define integration strategies and methods.
• Translate user requirements—including clinical, serviceability, reliability, and manufacturability needs—as well as regulatory requirements and system architecture into functional requirements.
• Manage requirements in accordance with requirements management policies and ensure their coverage, quality, and full implementation.
• Own the technical approach and top-level system design; assess the feasibility of potential technical solutions.
• 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.

Benefits

• Generous paid time off (PTO).
• 401(k) with up to 7% company match.
• Health Savings Account (HSA) with company contribution.
• Stock purchase plan.
• Education reimbursement.
• Other benefits through the Philips Total Rewards benefits program.
• Other compensation may include an annual incentive bonus, sales commission, or long-term incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level