System Engineer III - Medical Devices

System Engineer III

Onsite – Rutherford, NJ

Join a collaborative engineering team developing complex electromechanical and embedded medical device systems that combine hardware and software. This role offers the opportunity to lead system-level development from requirements and architecture through verification, testing, manufacturing, and commercialization in a highly regulated, FDA-focused environment.

What You’ll Do

• Lead systems engineering activities across the full product development lifecycle for complex embedded, real-time, and PC-based systems.
• Translate client and stakeholder needs into clear system and product requirements aligned with feasibility, schedule, and cost.
• Develop verification strategies, test plans, procedures, protocols, test cases, reports, and traceability documentation.
• Execute system testing, troubleshoot non-routine issues, and drive defects through resolution.
• Design and implement test equipment and tools, including appropriate qualification activities.
• Partner with mechanical, electrical, software, manufacturing, process, and test engineering teams to resolve cross-disciplinary issues.
• Support risk management, design reviews, and phase reviews within a regulated product development environment.
• Support manufacturing activities and ensure system-level functionality performs as expected.
• Maintain project documentation, requirements, testing, and traceability throughout development.
• Work directly with clients and technical stakeholders, including clinicians and marketing teams, to align solutions with product needs.
• Provide technical guidance and mentorship to junior Systems Engineers.
• Partner with project managers on proposals, designs, resource estimates, and process improvements.

What You Bring

• Bachelor’s degree in Mechanical, Electrical, Systems, or related Engineering.
• Ideally 8 years' experience developing electromechanical and embedded systems.
• Advanced understanding of systems engineering principles and product testing.
• Strong experience developing test protocols, engineering documentation, and defect reports.
• Ability to independently troubleshoot and resolve complex product and testing issues.
• Experience with white-box and/or automated testing is a plus.
• Familiarity with requirements management, source control, and defect tracking tools.
• Medical device experience strongly preferred, particularly FDA Class II/III products.
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1, or related medical device standards is a plus.
• Strong communication skills with the ability to explain technical concepts and testing protocols to cross-functional teams.

Location & Travel

• Rutherford, NJ – onsite initially, can transition into a hybrid model
• Onsite required for the first 90 days; hybrid may be considered afterward.
• Approximately 15 days of travel per year.
• Base salary plus annual discretionary bonus and merit increase consideration.