MedTech Systems Engineer II - Hybrid (Remote 1-2 days)

Getinge Group; Wayne (NJ); Hybrid; USD 100,000 - 105,000; Full time

Benefits offered by this job

Health insurance

401k plan with company match

Paid Time Off

Tuition Reimbursement

Life Insurance

Job summary

Getinge seeks an Engineer II, Systems in Wayne, NJ to support the development, verification, and troubleshooting of electromechanical medical devices. You will perform hands-on lab testing and manage requirements using Excel and JAMA, ensuring traceability and compliance with 21 CFR 820.30.

The role requires collaboration with cross-functional teams, contributing to design reviews, and driving improvements while maintaining product integrity and regulatory alignment.

Qualifications

• BS in Systems, Biomedical, Electrical, Software, or related Engineering with 3+ years of related experience.
• MS or PhD in Systems, Biomedical, Electrical, Software, or related Engineering with 2+ years of related experience.
• Experience with design controls and medical device development processes.
• Regulatory knowledge including 21 CFR 820.30 and ISO standards.

Responsibilities

• Support development and improvement of on-market electromechanical medical devices.
• Utilize Excel and JAMA to manage requirements and traceability.
• Collaborate with cross-functional teams to define scope and deliverables.
• Participate in design reviews and provide feedback for high-quality designs.
• Maintain current product while implementing innovative solutions and improvements.

Skills

Systems engineering

Regulatory compliance

Requirements management

Lab testing

Data analysis

Cross-functional collaboration

Problem solving

Education

BS in Systems/Biomedical/Electrical/Software

MS/PhD in Systems/Biomedical/Electrical/Software

Tools

JAMA

Excel

Job description

Getinge seeks an Engineer II, Systems in Wayne, NJ to support the development, verification, and troubleshooting of electromechanical medical devices. You will perform hands-on lab testing and manage requirements using Excel and JAMA, ensuring traceability and compliance with 21 CFR 820.30.

The role requires collaboration with cross-functional teams, contributing to design reviews, and driving improvements while maintaining product integrity and regulatory alignment.