Senior Engineer, Medical Device Sustaining (Hybrid)

Getinge Group; Wayne (NJ); Hybrid; USD 117,000 - 125,000; Full time

Job summary

Getinge is seeking a Sr. Engineer, Product Sustaining in Wayne, NJ. You will provide technical leadership for sustaining activities, investigate issues, and drive CAPA within a regulated medical device context.

Hybrid work available with on-site and some home-based days. The role requires a BS in Mechanical Engineering, 5+ years’ experience, and strong knowledge of FDA/ISO requirements. You will collaborates with Quality, Operations, Service, and Regulatory teams to ensure product reliability

Qualifications

• Bachelor of Science degree required; minimum 5 years of relevant engineering experience.
• Knowledge of GMP, FDA regulations, and ISO requirements.

Responsibilities

• Technical lead for sustaining engineering activities supporting released medical device products.
• Investigate product complaints, manufacturing nonconformances, field issues, and returned product failures.
• Design and implement engineering changes through change control processes.
• Prepare and maintain engineering documentation including drawings, specifications, test protocols, reports, and technical justifications.
• Perform engineering analyses including tolerance stack-up, stress calculations, material selection, and failure analysis.
• Conduct design verification and validation testing to support product changes.
• Support cost reduction projects, component/material changes, supplier changes, and obsolescence issues.
• Participate in root cause investigations and CAPA implementations.
• Ensure compliance with FDA QSR, ISO 13485, and applicable international standards.
• Provide technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support.
• Act as engineering lead on projects.
• Mentor junior engineers and provide guidance across sustaining projects.

Skills

Technical leadership

Cross-functional collaboration

Regulatory compliance

Problem solving

Communication

Education

Bachelor's in Mechanical Engineering

Tools

SolidWorks

Creo

Job description

Getinge is seeking a Sr. Engineer, Product Sustaining in Wayne, NJ. You will provide technical leadership for sustaining activities, investigate issues, and drive CAPA within a regulated medical device context.

Hybrid work available with on-site and some home-based days. The role requires a BS in Mechanical Engineering, 5+ years’ experience, and strong knowledge of FDA/ISO requirements. You will collaborates with Quality, Operations, Service, and Regulatory teams to ensure product reliability