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Senior Systems Engineer New Kensington, PA - Philips
Systems Engineer
Senior Systems Engineer leading cross‑functional teams to design, integrate, and validate next‑generation sleep therapy and ventilation devices, ensuring hardware and software cohesion, regulatory compliance, and scalable product delivery.
About the role
Key Responsibilities
- Define and reconcile system requirements across stakeholders, translating business goals into technical specifications.
- Lead system architecture and integration strategy, ensuring seamless hardware‑software interaction and optimal performance.
- Establish traceability of requirements, data models, and lifecycle decisions to measurable outcomes.
- Drive compliance with safety, regulatory, and quality standards throughout the product lifecycle.
- Collaborate with cross‑functional teams to make engineering trade‑offs that balance cost, risk, and time‑to‑market.
Requirements
- 5+ years of systems engineering experience in medical device or related high‑regulatory environment.
- Proven expertise in hardware‑software integration, architecture design, and requirements management.
- Strong understanding of safety, compliance, and quality processes (e.g., IEC 62304, FDA 21 CFR Part 820).
- Excellent communication skills for stakeholder alignment and technical documentation.
- Experience with lifecycle management tools and traceability frameworks.