Systems Engineer II, Med Device R&D | Remote 1-2 days

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

Benefits offered by this job

Health, Dental, and Vision insurance

401k with company match

Paid Time Off

Wellness resources

Life Insurance

Short/Long Disability

FSA/Dependent Care Accounts

Parental Leave

Tuition Reimbursement

Job summary

Getinge is seeking a Systems Engineer in Wayne, NJ to support development and improvement of on-market electromechanical medical devices. You will perform testing, data collection, and root cause analysis in a lab setting, ensuring traceability and regulatory compliance.

The role requires a BS/BE with 4+ years in regulated medical device development, experience with JAMA, and collaboration across cross-functional teams. Hybrid work with 1-2 days remote is available.

Qualifications

• BS or higher in a related engineering field with 4+ years in regulated medical device development.
• Experience with design controls and root cause investigations.
• Proficiency with requirements management tools (JAMA).
• Hands-on lab testing and data collection in engineering environments.

Responsibilities

• Support development and improvement of on-market electromechanical medical devices.
• Perform system-level testing, data collection, and root cause analysis.
• Ensure compliance with 21 CFR 820.30 and ISO standards.
• Collaborate with cross-functional teams on project scope and design reviews.

Skills

Engineering experience

Regulated product development

Requirements management (JAMA)

System-level testing

Regulatory standards (FDA 21 CFR 820.3

Analytical problem solving

Education

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

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

Tools

JAMA

Job description

Getinge is seeking a Systems Engineer in Wayne, NJ to support development and improvement of on-market electromechanical medical devices. You will perform testing, data collection, and root cause analysis in a lab setting, ensuring traceability and regulatory compliance.

The role requires a BS/BE with 4+ years in regulated medical device development, experience with JAMA, and collaboration across cross-functional teams. Hybrid work with 1-2 days remote is available.