Engineer II, Product Sustaining

Job Overview

The Product Sustaining Engineer II is responsible for sustaining engineering activities including product improvements, design changes, cost reduction initiatives, component obsolescence management, manufacturing support, complaint investigations, and corrective and preventive actions (CAPA). This position works under general supervision and collaborates with cross-functional teams to ensure product quality, regulatory compliance, reliability, and continuity of supply.

Job Responsibilities and Essential Duties

• 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.

Minimum Requirements

• Bachelor of Science degree (or equivalent), preferably in Mechanical Engineering.
• Minimum 3+ years of progressive and relevant engineering experience, preferably in the medical device or other regulated industry.
• Advanced degree considered in lieu of experience.
• General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.

Required Knowledge, Skills and Abilities

• Understanding of mechanical engineering principles, materials, manufacturing processes, and product development methodologies.
• Knowledge of engineering drawings, GD&T, tolerance analysis, and material properties.
• Understanding design of injection molded plastic, casting, sheet metal, machined components, and pneumatics preferred.
• Experience using CAD software such as SolidWorks, Creo, or equivalent preferred.
• Understanding of Design Control processes and engineering change management.
• Working knowledge of root cause analysis methodologies and problem-solving tools.
• Basic understanding of FDA regulations, ISO 13485, and other applicable medical device regulations preferred.
• 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.