Mechanical Engineer

Zenith Services Inc.; Palo Alto (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Zenith Services Inc. is seeking an experienced mechanical engineer to design and analyze components for Class 3 medical devices and to own end-to-end subsystem development.

You will collaborate with cross-functional teams, generate detailed CAD models in SolidWorks or CREO, develop prototypes, run validated tests, and ensure documentation and regulatory submissions are complete for production release. The role requires strong knowledge of GD&T, materials, finishes, and close vendor coordination

Qualifications

• Bachelor's degree in mechanical engineering (or equivalent) with 5+ years of related experience, or master's degree with 3+ years.
• Experience creating detailed mechanical designs.
• Experience with dimensioning and tolerancing (GD&T), materials and finishes, fabrication processes and assembly processes.
• Proficient in CAD systems: SolidWorks or CREO.
• Experience performing analysis using detailed calculations and software tools.
• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Interface with cross-functional counterparts to define subsystem requirements and failure modes.
• Use CAD to design and analyze mechanical and electromechanical components for Class 3 devices.
• Develop prototypes from manufacturing methods for engineering testing.
• Develop, execute, and automate testing protocols for performance and lifetimes.
• Collaborate with vendors to ensure quality and manufacturability.
• Document all phases of development for 510(k) regulatory submissions.
• Provide SME support to investigate and close customer complaints.
• Provide design information to drafting for packaging documentation.
• Leverage mechanics/materials knowledge to design and document EM systems.
• Own component and subsystem development from origination to production release.
• Interface with cross-functional counterparts to specify and realize key performance characteristics.

Skills

Mechanical design

GD&T

Engineering analysis

Vendor collaboration

Documentation

Education

Bachelor's degree in mechanical engineering

Master's degree (optional)

Tools

SolidWorks

CREO

Microsoft Office

Job description

• Interface with cross-functional counterparts to support definition of subsystem requirements and failure modes


• Use computer aided design software to design and analyze mechanical and electromechanical components for use in Class 3 medical devices


• Use diverse knowledge of manufacturing methods to develop prototypes for engineering testing and refinement


• Develop, execute, and automate testing protocols to confirm required performance and lifetimes of components and subassemblies


• Collaborate with vendors to ensure quality and manufacturability are maintained


• Document all phases of development process for inclusion in 510k regulatory submissions


• Provide subject matter expertise to assist with investigation and closure of reportable customer complaints


• Provide design information to drafting for packaging documentation


• Leverage knowledge of mechanics and materials to design, analyze, and document electromechanical systems and equipment


• Own component and subsystem development from origination through release to production


• Interface with cross-functional counterparts to specify and realize key performance characteristics

Required Qualifications:

• Bachelor's degree in mechanical engineering (or equivalent) and 5+ years of related experience or master's degree with 3+ years of related experience


• Experience creating detailed mechanical designs


• Experience with dimensioning and tolerancing (GD&T), materials and finishes, fabrication processes and assembly processes


• Proficient in CAD systems: SolidWorks or CREO


• Experience performing analysis using detailed calculations and software tools


• Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.