Senior Electro-mechanical Design Engineer

3 weeks ago


San Diego, United States CareerBuilder Full time

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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