Senior Mechanical Design Engineer – Automated Medical Equipment

DGN Technologies; Sunnyvale (CA); In loco; USD 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

DGN Technologies is seeking an experienced Mechanical Design Engineer to design and build in-house automated manufacturing equipment for minimally invasive medical devices. You will develop fixtures and complex assemblies, prototype and test designs, and ensure compliance with validation and documentation standards.

The role requires 5+ years in automated equipment design, strong CAD (SolidWorks) skills, and proven collaboration with cross-functional teams.

Competenze

• Minimum BSME or similar with 5+ years in automated equipment design.
• Experience with enterprise software (e.g. Agile document control, Confluence, Polarion, Windchill).
• Prior experience with PLM systems (Agile preferred), SAP including ECO creation, equipment specs, test protocols, BOM, and work instructions.

Mansioni

• Design in-house manufacturing equipment from concept to implementation.
• Create design solutions for mechanical assemblies from simple fixturing to complex automation equipment.
• Prototyping, testing, and validating designs using simulations and physical models.
• Ensure equipment designs meet functional, safety, ergonomic, documentation, and validation requirements.
• Develop and manage project plans including schedules, budgets, and stakeholder updates.
• Create and maintain equipment documentation including specs, assembly instructions, maintenance, and calibration procedures.
• Execute DQ/IQ/OQ/PQ validation protocols for equipment.
• Conduct design reviews at all development stages.
• Provide equipment-related technical support for production operations and expansion.
• Coordinate external resources (contractors, integrators, vendors) for equipment projects.

Conoscenze

CAD SolidWorks

Mechanical design

Mechatronics integration

Project planning

Team collaboration

Problem solving

Formazione

BSME or Mechatronics

PLM systems experience

Strumenti

SAP

Agile / Windchill / Confluence / Polarion

Descrizione del lavoro

DGN Technologies is seeking an experienced Mechanical Design Engineer to design and build in-house automated manufacturing equipment for minimally invasive medical devices. You will develop fixtures and complex assemblies, prototype and test designs, and ensure compliance with validation and documentation standards.

The role requires 5+ years in automated equipment design, strong CAD (SolidWorks) skills, and proven collaboration with cross-functional teams.