System Engineer III

Professional Employment Group; Olathe (KS); On-site; USD 95,000 - 135,000; Full time

Job summary

Professional Employment Group seeks an experienced Systems Engineer for onsite roles in New Jersey. You will own system-level requirements, verification, and risk management for electromechanical, embedded medical devices and work with clinicians and engineers across disciplines.

The role emphasizes mentoring junior engineers, cross-functional collaboration, and ensuring compliance with FDA Class II/III processes and ISO 13485/14971 standards. Onsite with light travel (~15 days/year).

Qualifications

• 8–10+ years of Systems Engineering experience.
• Strong background in electromechanical + embedded medical devices.
• Strong systems requirements development and management experience.
• Experience with verification/validation and traceability.
• Experience with risk management and design/phase reviews.
• Excellent documentation, communication, and problem-solving skills.
• Mentoring junior Systems Engineers and cross-functional collaboration.
• Client-facing experience with clinicians/technical teams.

Responsibilities

• Lead systems engineering activities across the product development lifecycle.
• Develop and manage systems requirements, verification plans, and traceability matrices.
• Mentor junior engineers and collaborate with ME, EE, Software, Manufacturing and Test teams.
• Engage in risk management, design reviews, and regulatory considerations.

Job description

• 8–10+ years of Systems Engineering experience
• BS in Mechanical, Electrical, Systems, or related Engineering
• Strong background in electromechanical + embedded medical devices
• Experience across the full product development lifecycle — requirements ? architecture ? verification/testing ? commercialization/manufacturing
• Strong systems requirements development and management experience
• Experience developing test strategies, protocols, procedures, test cases, and reports
• Strong verification/validation and traceability experience
• Experience with risk management and design/phase reviews
• Experience troubleshooting hardware/software/system-level issues
• Background working cross-functionally with ME, EE, Software, Manufacturing, Process, and Test Engineering
• Medical device experience strongly preferred, especially FDA Class II/III
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1 and other medical device standards
• Experience with white-box testing and automated testing
• Familiarity with requirements management, source control, and defect tracking tools
• Strong documentation, communication, and technical problem-solving skills
• Must be comfortable mentoring junior Systems Engineers
• Client-facing experience and ability to work with technical experts, clinicians, and/or marketing
• Onsite in NJ, with light travel (~15 days/year)

Biggest priorities:

Systems Engineering + medical devices + requirements/traceability + verification/testing + FDA/regulatory + electromechanical/embedded systems.

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