Sr. Engineer, Product Sustaining - Wayne, NJ

Getinge•Wayne, NJ

1d•$117,000 - $125,000

About The Position

The Product Sustaining Sr. Engineer provides technical leadership and engineering support for sustaining activities involving released medical device products. The role supports product improvements, design changes, cost reduction, component obsolescence management, manufacturing, complaint investigations, and corrective and preventive actions (CAPA). Working with minimal supervision, the engineer collaborates with cross-functional teams to ensure product quality, regulatory compliance, reliability, and continuity of supply.

Requirements

Bachelor of Science degree or equivalent, preferably in Mechanical Engineering.
At least 5 years of progressive, relevant engineering experience, preferably in the medical device or another regulated industry; an advanced degree may be accepted 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 lead cross-functional teams and influence without direct authority.
Ability to manage multiple projects and priorities in a fast-paced environment.

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

Lead 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 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 implement 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.
Act as engineering lead on projects.
Mentor junior engineers and provide technical guidance across sustaining engineering projects.