Systems Engineer

Philips; New Kensington (Westmoreland County); On-site; USD 102,000 - 163,000; Full time

Benefits offered by this job

PTO

401(k) match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Systems Engineer in New Kensington, PA to lead system-level design for Sleep and Respiratory Care devices. You will translate user and regulatory requirements into product specifications, drive architecture development, and coordinate subsystem integration across projects.

Ideal candidates have 2+ years in medical devices with MBSE experience, strong emphasis on patient safety, and familiarity with FDA/ISO quality systems.

Qualifications

• 2+ years of experience developing complex medical devices with a focus in systems engineering (hardware, software, consumables).
• Experience in Sleep Therapy/Ventilation products and accessories is highly desired.
• Bachelor’s degree in Engineering required; Master’s degree preferred.

Responsibilities

• Owns system-level deliverables and translates user/business requirements into product requirements and architecture.
• Leads refinement and translation of requirements to functional specs; ensures coverage and traceability.
• Plans and executes system-level design reviews and allocates requirements to subsystems.
• Manages system integration, verification, and validation with defect analysis and risk management.
• Conducts DFMEA and supports regulatory and country approvals.

Skills

MBSE

Requirements engineering

System architecture

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s Degree in Engineering

Master’s degree preferred

Tools

DFMEA

Job description

Job Description

Systems Engineer (New Kensington, PA)

You 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.

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.

You're the right fit if:

• You’ve acquired 2+ years 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. 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.
• Your skills include strong understanding of System Design process, including Model-Based (MBSE/V Model) Design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation, Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562 ,17510 2015, IEC 62366 etc.) and clearance processes.
• You have a Bachelor’s Degree, required in Engineering preferably in Systems, Biomedical, Mechanical or similar discipline, 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.
• You’ve demonstrated a relentless focus on Patient Safety and Quality as an organizational value and bring highly effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in New Kensington, PA is $102,000 to $163,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to New Kensington, PA.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.