MedTech Systems Engineer, R&D — Hybrid (1-2 Remote)

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

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Flexible Spending Accounts

Job summary

Getinge is seeking an Engineer, System R&D to join our Wayne, NJ team. The role focuses on supporting development, verification, and troubleshooting of on-market electromechanical medical devices, with hands-on lab work and data collection.

You will use Excel and JAMA for requirements management and traceability, drive improvements, and ensure compliance with 21 CFR 820.30 and applicable standards. Collaboration with cross-functional teams is essential for success.

Qualifications

• BS or MS/PhD in engineering with related systems engineering experience.
• Experience in regulated product development and design controls.
• Familiarity with 21 CFR 820.30 and ISO standards.

Responsibilities

• Support development and improvement of on-market electromechanical medical devices.
• Use Excel and JAMA to manage requirements and traceability.
• Conduct system-level testing and root cause investigations in lab.
• Collaborate with cross-functional teams to define scope and deliverables.
• Participate in design reviews and provide feedback for quality designs.
• Maintain and improve current products with innovative solutions.
• Ensure compliance with regulatory requirements and standards.

Skills

Requirements management

Traceability

Design controls

Regulatory compliance

Root cause analysis

Lab testing

Cross-functional collaboration

Problem solving

Communication

Education

BS in Systems, Biomedical, Electrical, Software, or related Engineering

MS or PhD in Systems, Biomedical, Electrical, Software, or related Engineering

Tools

JAMA

Excel

Job description

Getinge is seeking an Engineer, System R&D to join our Wayne, NJ team. The role focuses on supporting development, verification, and troubleshooting of on-market electromechanical medical devices, with hands-on lab work and data collection.

You will use Excel and JAMA for requirements management and traceability, drive improvements, and ensure compliance with 21 CFR 820.30 and applicable standards. Collaboration with cross-functional teams is essential for success.