Job Details

Senior Mechanical Engineer - Medical Device

On-Site, Hayward, CA

12 Month Contract (May extend or convert to permanent)

$66.75/hour W2

Job Summary

We are seeking a Senior Mechanical Engineer to play a critical role in sustaining the manufacturing of DNA sequencing systems. This position focuses on maintaining and improving existing products to ensure reliability and high performance. You will be the technical bridge between design and production, spending approximately 70% of your time on desk-based engineering and 30% on the production floor performing root cause assessments.

Key Responsibilities

• Sustaining & Component Qualification: Identify replacement components and execute qualifications to ensure they meet stringent requirements for instrument builds.
• Root Cause Analysis: Regularly assess the manufacturing floor to troubleshoot mechanical failures and implement corrective actions.
• Documentation & CAD: Perform basic mechanical updates to drawings using SolidWorks and GD&T standards.
• Change Management: Manage the end-to-end engineering change process, including updating Bills of Materials (BOM) and maintaining data within the SAP system.
• Project Leadership: Execute verification/validation protocols and manage project timelines, including planning, budgeting, and reporting.
• Daily Operations: Maintain project dashboards, update status reports, and drive engineering qualifications to completion.

Qualifications & Requirements

Education & Experience:

• Master's Degree (M.S.) in Mechanical or Industrial Engineering with 5+ years of experience OR
• Bachelor's Degree (B.S.) in Mechanical or Industrial Engineering with 8+ years of experience.

Must-Have Technical Skills:

• CAD Expert: Advanced proficiency in SolidWorks is required.
• Precision Standards: Strong working knowledge of GD&T and material properties (fabrication methods, manufacturing processes).
• Systems: Proficiency in SAP and Office 365.
• Regulatory: Experience in a medical device or highly regulated environment (FDA/ISO standards).

Soft Skills:

• Project Management: Proven ability to handle a project from concept and planning through to closing.
• Communication: Strong verbal and written skills for cross-functional collaboration and dashboard reporting.

Physical Requirements

• Ability to walk the manufacturing floor (up to 30% of the day) to assess equipment and investigate technical issues.