Senior Mechanical Engineer Manufacturing Equipment

Intuitive - Sunnyvale, CA

Full-time

Sunnyvale, CA

Miscellaneous Manufacturing

About the position

The position involves designing and constructing manufacturing equipment for producing minimally invasive medical devices. The role is critical in developing advanced manufacturing capabilities that support the future of minimally invasive surgery. The ideal candidate will work independently on complex projects and collaborate with senior equipment staff and other departments to create custom equipment for production use.

Responsibilities

• Design and build in-house manufacturing equipment from concept to implementation.
• Create effective design solutions for mechanical assemblies, ranging from simple fixturing to complex automation equipment.
• Ensure manufacturing equipment designs meet functional, safety, ergonomic, documentation, and validation requirements.
• Create and manage project plans including schedules, budgets, and stakeholder updates.
• Develop documentation for equipment including specifications, assembly instructions, maintenance, and calibration procedures.
• Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations.
• Conduct effective design reviews of new equipment at all stages of development.
• Provide equipment-related technical support for ongoing production operation and expansion.
• Establish and manage external resources (contractors, system integrators, vendors) in the planning and execution of equipment projects.
• Support quality and internal/external audits as required.
• Support other equipment-related operations and duties as required.

Requirements

• Minimum BSME or similar degree.
• Minimum 4 years' experience designing and developing automated manufacturing equipment.
• Self-motivated and able to work well in a team environment.
• Proficiency in 3D CAD, preferably SolidWorks.
• Experience in integration of mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.
• Strong understanding of tolerance analysis and statistical methods.
• Experience troubleshooting and repairing manufacturing equipment.
• Experience developing equipment qualification, calibration, and PM procedures and practices.

Nice-to-haves

• MSME (or equivalent) with a minimum of 6 years prior experience.
• Prior experience developing and supporting catheter manufacturing equipment.
• Knowledge in equipment control systems, PLC (Beckhoff preferred).
• Prior experience working with PLM systems (Agile preferred), SAP applications, including ECO creation, origination of equipment specification, test protocols, BOM, and work instructions.
• Structured Problem Solving skills.
• Rational thinking and root cause analysis capability.
• Experience with enterprise software (e.g., Agile document control, Confluence, Polarion, Windchill, etc.).
• Experience working in a medical device or other regulated quality systems.

Benefits

• Market-competitive compensation packages, including base pay, incentives, benefits, and equity.