Hybrid Systems R&D Engineer — Medical Device & Lab Testing

Getinge; Wayne (NJ); Hybrid; USD 96,000 - 99,000; Full time

Benefits offered by this job

Health & Wellness Benefits

401(k) matching

Paid Time Off

Job summary

Getinge seeks a Systems Engineer to support electromechanical medical devices in Wayne, NJ. You will perform system-level testing, data collection, and root cause assessment in a lab, ensuring compliance with 21 CFR 820.30 and ISO standards. Expect collaboration across teams and design reviews.

Experience in regulated development, requirements management, and problem solving is required. A BS or higher in related engineering disciplines is preferred, with a focus on maintaining and improving

Qualifications

• Experience in regulated product development and software/hardware integration.
• Proficiency with requirements management and traceability tools.
• Knowledge of ISO 14971/13485 and 21 CFR 820.30.
• Experience with design verification and system-level testing.

Responsibilities

• Support development and improvement of on-market electromechanical devices.
• Use Excel and JAMA to manage requirements and traceability.
• Conduct system-level testing, troubleshooting, data collection and root cause analysis.
• Collaborate across cross-functional teams to define scope and deliverables.
• Participate in design reviews and provide constructive feedback.
• Maintain and improve the current product with innovative solutions.
• Ensure compliance with regulatory requirements and standards.

Skills

Requirements management

System-level testing

Regulatory compliance

Root cause analysis

Troubleshooting

Excel

Cross-functional teamwork

Communication

Problem solving

Documentation

Education

BS in Systems Engineering or related

MS/PhD in Systems Engineering or related

Tools

JAMA

Job description

Getinge seeks a Systems Engineer to support electromechanical medical devices in Wayne, NJ. You will perform system-level testing, data collection, and root cause assessment in a lab, ensuring compliance with 21 CFR 820.30 and ISO standards. Expect collaboration across teams and design reviews.

Experience in regulated development, requirements management, and problem solving is required. A BS or higher in related engineering disciplines is preferred, with a focus on maintaining and improving