Engineer II, Product Sustaining - Wayne, NJ

Getinge•Wayne, NJ

2d•$100,000 - $105,000•Hybrid

About The Position

The Product Sustaining Engineer II supports sustaining engineering activities for released medical device products, including product improvements, design changes, cost reduction initiatives, component obsolescence management, manufacturing support, complaint investigations, and corrective and preventive actions (CAPA). Working under general supervision, this position collaborates with cross-functional teams to support product quality, regulatory compliance, reliability, and continuity of supply. The role investigates product complaints, manufacturing nonconformances, field issues, and returned product failures; develops and implements engineering changes; prepares and maintains engineering documentation; performs engineering analyses; and conducts design verification and validation testing. It also supports supplier, component, and material changes and provides technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support.

Requirements

Bachelor of Science degree or equivalent, preferably in Mechanical Engineering.
At least 3 years of progressive and relevant engineering experience; an advanced degree may be considered in lieu of experience.
General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
Understanding of mechanical engineering principles, materials, manufacturing processes, and product development methodologies.
Knowledge of engineering drawings, GD&T, tolerance analysis, and material properties.
Understanding of Design Control processes and engineering change management.
Working knowledge of root cause analysis methodologies and problem-solving tools.
Strong analytical and problem-solving skills.
Self-motivated, with the ability to accomplish project goals with minimal supervision.
Effective verbal and written communication skills.
Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
Ability to work effectively within cross-functional teams.
Ability to manage multiple priorities while meeting project deadlines.

Nice To Haves

Experience in the medical device or another regulated industry.
Understanding of the design of injection-molded plastic, cast, sheet-metal, and machined components, and pneumatics.
Experience using CAD software such as SolidWorks, Creo, or equivalent.
Basic understanding of FDA regulations, ISO 13485, and other applicable medical device regulations.

Responsibilities

Support sustaining engineering activities for released medical device products.
Investigate product complaints, manufacturing nonconformances, field issues, and returned product failures.
Design and implement engineering changes through established change control processes.
Prepare and maintain engineering documentation, including drawings, specifications, test protocols, reports, and technical justifications.
Perform engineering analyses, including tolerance stack-up analyses, stress calculations, material selection, and failure analysis.
Conduct design verification and validation testing to support product changes.
Support cost reduction projects, component and material changes, supplier changes, and product obsolescence issues.
Participate in root cause investigations and implementation of corrective and preventive actions (CAPA).
Ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and applicable international regulatory standards.
Provide technical support to Quality, Operations, Service, Regulatory Affairs, and Customer Support organizations.