Systems Engineer

Systems Engineer – Contract
Location: New Kensington, Pennsylvania

Schedule: Hybrid, 3 days onsite | 40 hrs/week
Contract: 1/23/2026 – 1/22/2027
Openings: 8
Local to Pennsylvania required

We’re seeking experienced Systems Engineers for a long-term hybrid contract supporting complex medical device product development. This role is ideal for someone who can lead systems-level analysis, translate standards into requirements, support risk management, and collaborate across software, electrical, mechanical, R&D, manufacturing, and regulatory teams.

What You’ll Do

Develop product, element, and subsystem requirements with clear rationales
Decompose medical device standards including IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72
Lead FMEA activities and connect risks to specific system and subsystem requirements
Support Risk Management File and Design History File documentation
Build trace matrices across the V-model
Develop V&V protocols, test plans, and technical reviews
Partner cross-functionally to drive systems engineering strategy and process improvements

Requirements

Bachelor’s degree with 5+ years of experience, or Master’s degree with 3+ years of experience
Background in systems architecture, systems design, hardware engineering, or related engineering work
Experience with electromechanical devices involving hardware and software
Strong understanding of medical device standards, risk management, and product development lifecycle
NPD / full product lifecycle experience strongly preferred
CSEP certification preferred

This is a strong opportunity for a senior systems engineering professional who enjoys solving complex technical challenges in a regulated medical device environment.

job.com is an Equal Opportunity employer