Senior Systems Engineer – Med Device, FDA-Ready, Onsite NJ

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

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).