Mechanical Design Engineer 3

DGN Technologies; Sunnyvale (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CAD SolidWorks

Mechanical design

Mechatronics integration

Project planning

Team collaboration

Problem solving

Education

BSME or Mechatronics

PLM systems experience

Tools

SAP

Agile / Windchill / Confluence / Polarion

Job description

Primary Function of Position

Design and construct manufacturing equipment used to produce minimally invasive medical devices. This equipment will range in complexity from custom manual fixtures to semi-automated electro-mechanical systems, integrating work-holding, sensing, motion and vision control. This position will play a critical role in developing cutting edge manufacturing capabilities to enable the future of minimally invasive surgery.

The ideal candidate should have a solid understanding of the technical aspects of mechanical engineering and design. He/she will work closely with senior level equipment staff and other departments to develop and sustain custom equipment for production use. This person will thrive working autonomously on projects with medium to high complexity.

Essential Job Duties

• Design and build in-house manufacturing equipment from concept to implementation.
• Create effective design solutions of mechanical assemblies from simple fixturing to more complex assembly for automation equipment.
• Iterate rapidly by prototyping, testing, and examining product designs using engineering methods and techniques, including computer simulation and physical models
• 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 on-going production operation and expansion.
• Establish and manage external resources (contractors, system integrators, vendors) in the planning and execution of equipment projects including duplication activities.
• Support other equipment-related operations and duties as required Qualifications Required Skills and Experience
• Minimum BSME or similar.
• Minimum 3 years' experience designing and developing Automated manufacturing equipment.
• Self-motivated, works well with others in a team environment.
• Proficiency with CAD (SolidWorks highly preferred): designing parts with complex geometry, creating assemblies and creating detailed manufacturing drawings
• Comfortable operating machine shop, measurement, and test equipment
• Mechanical design and exploration skills, including statics, dynamics, and strength of materials, including stress analysis, fatigue, and thermal
• Experience in integration of mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.
• Experience troubleshooting and repair of manufacturing equipment.
• Experience developing equipment qualification, calibration and PM procedures and practices.

Required Education and Training

• Minimum BSME Mechanical or Mechatronics engineering with minimum of 5 years related experience.
• Experience with enterprise software (e.g. Agile document control, Confluence, Polarion, Windchill, etc)
• Prior experience working with PLM systems (Agile preferred), SAP applications, including ECO creation, origination of equipment specification, test protocols, BOM, and work instructions.

Preferred Skills and Experience

• Excellent understanding of tolerance analysis and statistical methods. Fluency in ASME
• Y14.5 GD&T and tolerance stack analysis
• MSME (or equivalent) with minimum 6 plus years prior experience.
• Structured Problem Solving. Rational thinking and root cause analysis capability.
• Experience working in a medical device or other regulated quality systems.