Senior Mechanical Engineer - Sustaining

Position Summary:

The Senior Sustaining Mechanical Engineer will play a key role in the support, improvement, and lifecycle management of existing electromechanical medical devices and their sterile disposable counterparts. This role involves analyzing, modifying, and enhancing current designs to improve performance, reliability, manufacturability, and compliance with evolving regulatory requirements. Responsibilities include leading and executing design modifications, failure analysis, root cause investigations, and product enhancements. This involves requirements assessment, engineering modeling and analysis, development of test methods and fixtures, and collaboration with suppliers to ensure high-quality, cost-effective solutions. Significant creativity and experience are essential for applying engineering principles to analyzing and verifying components (machined, sheet metal, injection molded, extruded, etc.), assemblies, mechanisms, and systems. The Senior Sustaining Mechanical Engineer must be a self-starter capable of driving continuous improvement initiatives, addressing field and production issues, and collaborating with cross-functional teams to maintain and optimize product performance throughout its lifecycle.

Primary Duties and Responsibilities:

• Support and improve capital medical equipment and sterile disposables by designing, developing, modifying, and testing mechanical components.
• Ensure reliability, manufacturability, serviceability, and compliance while maintaining design quality.
• Diagnose and resolve mechanical system failures, implementing design modifications as needed.
• Specify, qualify, and document new mechanical design updates using appropriate materials and manufacturing processes.
• Conduct design verification and validation testing for electromechanical medical devices and disposables.
• Create and manage engineering documentation, including design specifications, test plans, CAD models, and change orders.
• Interface with Operations and Manufacturing teams to ensure smooth product transitions and support production troubleshooting.
• Drive continuous improvement initiatives for quality, reliability, and cost optimization of existing products.
• Ensure compliance with regulatory and quality standards (FDA, UL, REACH/RoHS, MDD/MDR).
• Work with cross-functional teams to evaluate design constraints, trade-offs, and project deliverables.
• Manage multiple projects, track milestones, and maintain effective communication with stakeholders.
• Collaborate with vendors and contract manufacturers to ensure compliance with product specifications and quality standards.