Systems Engineer II, Medical Devices — Impactful Lab Work

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

Benefits offered by this job

Health insurance

Dental & Vision insurance

401k with company match

Paid Time Off

Tuition Reimbursement

Commuter Benefits

Job summary

Getinge in Wayne, NJ is seeking a Systems Engineer to join a multidisciplinary team, supporting on-market electromechanical medical devices. You will assist with development, verification and troubleshooting, using Excel and JAMA for requirements management and traceability.

This role emphasizes compliance with 21 CFR 820.30, ISO 13485, and design controls. You will work in the lab, perform tests, collect data, analyze root causes, and help implement improvements while maintaining current

Qualifications

• BS or MS/PhD with specified years in regulated medical device development.
• Experience with design controls (21 CFR 820.30) and risk management.

Responsibilities

• Support development and improvement of on-market electromechanical medical devices, ensuring scalable and maintainable solutions.
• Utilize Excel and JAMA to manage requirements, track progress, and ensure traceability.
• Perform system-level testing, data collection, test setup execution, and root cause assessment in the engineering lab.
• Collaborate with cross-functional teams to define scope, objectives, and deliverables.
• Participate in design reviews and provide constructive feedback to ensure high-quality designs.
• Maintain the current product while implementing innovative solutions and improvements.
• Drive product improvements based on data and feedback.
• Ensure compliance with regulatory requirements and standards.

Skills

Regulated product development

Requirements management

Systems engineering

Regulatory knowledge

Root cause investigation

Education

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

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

Tools

JAMA for requirements management

Job description

Getinge in Wayne, NJ is seeking a Systems Engineer to join a multidisciplinary team, supporting on-market electromechanical medical devices. You will assist with development, verification and troubleshooting, using Excel and JAMA for requirements management and traceability.

This role emphasizes compliance with 21 CFR 820.30, ISO 13485, and design controls. You will work in the lab, perform tests, collect data, analyze root causes, and help implement improvements while maintaining current