Sustaining Engineer

Description:

The Sustaining Engineer is a technical leader responsible for supporting commercially released medical devices throughout their lifecycle. This role ensures product performance, safety, reliability, documentation and regulatory compliance while driving continuous improvement. The position leads complex investigations, mentors junior engineers, and owns cross-functional technical initiatives in a regulated environment.

Duties and Responsibilities:

Serve as technical lead for sustaining engineering activities. Ensures gaps in legacy engineering documents, design intent, effectiveness checks, reliability are mitigated to produce high quality and compliant products. Helps with internal audits, and systemic improvements. Partners with Quality, Regulatory Affairs, Manufacturing, and Supply Chain to ensure compliance and seamless integration. Lead supplier technical assessments, material substitutions, design controls, and component obsolescence strategies. Creates/updates drawings to ensure critical elements are well established and aligned with manufacturability and inspection capability and requirements. Reviews/updates/creates Device Master Record (DMR), Design History File (DHF), BOM and other technical documentation for new and existing products. Supports other Project Leads with engineering deliverables as needed. Checks for integrity and accuracy between ERP and engineering documents. Other duties as assigned.

Requirements:

Must be able to read, write, and speak the English language and be understood. Bachelor's degree in mechanical engineering, or equivalent Ability to work independently with limited supervision. Ability to work in Cross-functional Team. Ability to read and understand protocols, test methods, drawings, and specifications. Mentor to junior engineering staff. Project management for complex product development projects. Technical expert, capable of solving complex engineering problems. Maintain up-to-date knowledge of industry requirements & best practices. Write and support development of project proposals / business cases for new products & design changes. Present design & summary of research results to cross-functional teams. Other duties as assigned.

Required Qualifications:

Bachelor's degree in engineering, or equivalent. Minimum of 5 years' related experience in an FDA/GMP regulated industry. Experience/understanding of quality management system software (for accessing and creating controlled documents for medical devices). Experience with 3D software (SolidWorks preferred). Physical /

Mental Demands:

Working conditions are normal for an office environment. Work may require travel. Work under stress in a challenging environment. Must be alert, able to concentrate, and use good judgment.