Senior Engineer, Product Sustaining — Life-Saving Tech

Getinge; Wayne (NJ); On-site; USD 117,000 - 125,000; Full time

Benefits offered by this job

Health benefits

401k match

Paid time off

Tuition reimbursement

Job summary

Getinge is seeking a Product Sustaining Senior Engineer in the United States to lead sustaining engineering activities for medical device products. You will investigate complaints, design and implement changes, maintain technical documentation, and ensure compliance with FDA QSR and ISO 13485 standards.

The role requires 5+ years in a regulated environment, strong CAD and problem-solving skills, and the ability to lead cross-functional teams with minimal supervision.

Qualifications

• Bachelor degree in Mechanical Engineering or equivalent.
• 5+ years in medical device or regulated industry preferred.
• Experience with design controls and change management advantageous.

Responsibilities

• Technical lead for sustaining engineering activities on released medical device products.
• Investigate complaints, nonconformances, field issues, and failures.
• Design and implement engineering changes via change control processes.
• Prepare and maintain engineering docs, specs, tests, and reports.
• Perform analyses including tolerance stack-ups and stress calculations.
• Conduct design verification and validation testing for product changes.
• Support cost reduction projects and obsolescence issues.
• Lead root cause investigations and CAPA implementations.
• Ensure compliance with FDA QSR, ISO 13485, and other standards.
• Provide technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support.
• Act as engineering lead on projects and mentor juniors.

Skills

Mechanical engineering knowledge

GD&T

CAD software (SolidWorks/Creo)

Regulatory knowledge (FDA/ISO)

Problem solving

Cross-functional leadership

Education

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks/Creo CAD

Microsoft Office

Job description

Getinge is seeking a Product Sustaining Senior Engineer in the United States to lead sustaining engineering activities for medical device products. You will investigate complaints, design and implement changes, maintain technical documentation, and ensure compliance with FDA QSR and ISO 13485 standards.

The role requires 5+ years in a regulated environment, strong CAD and problem-solving skills, and the ability to lead cross-functional teams with minimal supervision.