Product Sustaining Engineer II - Hybrid (Medical Devices)

Getinge; Wayne (NJ); Hybrid; USD 100.000 - 105.000; Vollzeit

Benefits dieser Stelle

Health Insurance

401k Plan with company match

Paid Time Off

Wellness initiative & Health Resources

Life Insurance

Short and Long Term Disability

Flexible Spending Accounts

Parental and Caregiver Leave

Tuition Reimbursement

Zusammenfassung

Getinge is seeking a Product Sustaining Engineer II in Wayne, NJ, to support sustaining activities for released medical devices, including design changes and CAPA, while ensuring regulatory compliance and supply continuity.

You will analyze complaints, perform engineering changes, and prepare technical documentation in a collaborative, cross-functional environment with a focus on quality and cost reduction. A B.S. in Mechanical Engineering and 3+ years in a regulated field are required.

Qualifikationen

• B.S. in Mechanical Engineering; advanced degree considered in lieu of experience
• 3+ years in progressive engineering roles, preferably in medical device or regulated industry
• Knowledge of FDA regulations, ISO 13485, and GMPs
• Experience with CAD and engineering drawings; GD&T and tolerance analyses
• Familiarity with design changes and CAPA processes
• Strong analytical and communication skills
• Ability to work cross-functionally and manage multiple priorities

Aufgaben

• Sustain engineering activities for released medical devices.
• Investigate complaints, nonconformances, field issues, and failures.
• Design and implement engineering changes through change control processes.
• Prepare drawings, specs, test protocols, reports and justifications.
• Perform tolerance, stress, material, and failure analyses.
• Conduct design verification/validation testing for changes.
• Support cost reduction, obsolescence, supplier and material changes.
• Participate in root cause investigations and CAPA implementations.
• Ensure compliance with FDA QSR, ISO 13485 and international standards.
• Provide technical support to QA, Operations, Regulatory and Customer Support.

Kenntnisse

Mechanical engineering principles

GD&T

Design for injection molded components

CAD software (SolidWorks/Creo)

Design control

Root cause analysis

FDA/ISO regulations

Analytical problem-solving

cross-functional teamwork

multitasking and prioritization

Ausbildung

Bachelor of Science in Mechanical Engineering

Tools

SolidWorks

Creo

Jobbeschreibung

Getinge is seeking a Product Sustaining Engineer II in Wayne, NJ, to support sustaining activities for released medical devices, including design changes and CAPA, while ensuring regulatory compliance and supply continuity.

You will analyze complaints, perform engineering changes, and prepare technical documentation in a collaborative, cross-functional environment with a focus on quality and cost reduction. A B.S. in Mechanical Engineering and 3+ years in a regulated field are required.