Sr. Mechanical Engineer, Manufacturing Equipment
On-siteSunnyvale, California, United States
Job Summary
Design and build in-house proprietary manufacturing and test equipment from concept to full implementation, creating mechanical assemblies ranging from simple fixturing to complex automation systems. Establish specifications, assembly instructions, troubleshooting guides, and maintenance procedures while ensuring designs meet functional, safety, and validation requirements. Create and manage project plans including schedules, budgets, and stakeholder updates, conducting design reviews and executing IQ/OQ/PQ validation protocols. Interface with technical teams and manage external resources such as contractors and vendors to sustain production operations and support audits.
Required Qualifications
- Minimum 6 years of manufacturing equipment design experience
- Self-motivated, works well with others in a team environment
- 3D CAD proficiency
- Hands-on experience in developing mechanical and mechatronics hardware involving motion, pneumatics, vision, sensors, PLCs, electronics and controls
- Experience in troubleshooting and repair of manufacturing equipment
- Strong understanding of tolerance analysis and statistical methods
- Strong verbal and written communication skills
- excellent interpersonal skills
- Minimum BS in Mechanical Engineering, Mechatronics Engineering or related fields
Desired Qualifications
- MSME (or equivalent) with minimum 6 years of prior experience
- Experience developing and supporting manufacturing equipment with robotic or catheter emphasis
- Experience in a medical device or similarly regulated environment
- Knowledge in equipment control systems, PLC (Beckhoff preferred)
- Hands-on experience in establishing equipment specification, validation protocols and reports, BOMs and work instructions
- Experience with change control (ECOs) and enterprise software (e.g. Agile document control, Confluence, Jira, Polarion, Windchill, etc...)
- Structured Problem Solving
- Rational thinking and root cause analysis capability
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