Senior Electro-mechanical Design Engineer
4 weeks ago
Responsibilities
· Design and development of complex electro-mechanical medical devices using SolidWorks and Altium Designer software.
· Translate engineering requirements into innovative and manufacturable designs.
· Perform advanced design calculations and analyses to verify product performance, reliability, and regulatory compliance.
· Independently select, specify, and source electrical and mechanical components for optimal functionality.
· Champion design control principles and ensure meticulous adherence to ISO 13485 quality management system throughout the entire development lifecycle.
· Hands-on mechanical and electrical assembly, testing for verification & validation (V&V) activities for prototypes and first articles.
· Mentor and guide other engineers, fostering a collaborative and supportive design environment.
· Prepare detailed design documentation, including drawings, specifications, bill of materials, and reports.
· Participate in design reviews, presenting findings and recommendations to cross-functional teams (engineering, quality, regulatory).
· Stay up-to-date on the latest advancements in medical device technology and relevant regulatory requirements.
· Other duties as assigned by management.
Qualifications
· Minimum 10+ years of experience in electro-mechanical design for the medical device industry.
· Proven track record of successfully leading and completing complex medical device design projects.
· Experience with various fabrication processes (plastic injection molding, sheet metal, printed circuit board fabrication, and assembly)
· Experience with small motor-driven mechanisms and small air pump delivery systems.
· Experience with Design for Manufacturing and Assembly (DFMA) principles.
· Experience working with a variety of medical device materials and manufacturing processes.
· Familiarity with risk management processes (FMEA, FTA) in a medical device environment.
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