Senior Mechanical Engineer - Supplier Relocation Lead

Hydrogen Group; Hayward (CA); On-site; USD 87,000 - 94,000; Full time

Job summary

Hydrogen Group is seeking a Senior Mechanical Engineer onsite in Hayward, CA to lead supplier-relocation projects for DNA sequencing systems.

You will review drawings, coordinate with suppliers, and drive verification, validation, and qualification activities to ensure design integrity and regulatory compliance throughout transfers. This role demands strong project management and cross-functional collaboration in a regulated manufacturing setting.

Qualifications

• Master's degree in Mechanical Engineering with 5+ years of relevant experience.
• Bachelor's degree in Mechanical Engineering with 8+ years of relevant experience.
• Experience in sustaining engineering, supplier quality, part qualification, or manufacturing transfer.
• Experience in life sciences, medical devices, or another regulated industry preferred.
• Demonstrated experience with mechanical design, SolidWorks, GD&T, precision assemblies, materials, and manufacturing processes.
• Experience leading supplier technical investigations, root-cause analysis, and corrective actions.
• Experience preparing engineering documentation and managing qualification activities through final approval.
• Experience working with FDA-regulated products is a plus.
• Previous should-cost analysis experience is a plus.

Responsibilities

• Lead engineering activities to qualify supplier relocations for DNA sequencing systems.
• Ensure mechanical components, assemblies, and processes meet design, quality, reliability, and performance standards when production moves to a new supplier or location.
• Lead supplier-relocation projects with qualification plans, schedules, budgets, and risk assessments.
• Review engineering drawings, BOMs, manufacturing processes, tooling, and inspection methods.
• Work with suppliers to collect documentation, samples, inspection records, material certifications, and validation evidence.
• Develop and execute verification and validation plans, dimensional inspections, functional testing, and process-capability studies.
• Identify and resolve supplier quality issues, qualification failures, and manufacturing-related problems.
• Collaborate with Quality, Manufacturing, Supply Chain, Regulatory, and Process Engineering teams for approvals.
• Manage engineering changes, supplier approvals, documentation updates, release-to-manufacturing.
• Maintain qualification records and ensure timelines and budgets are met.

Skills

SolidWorks

GD&T

Mechanical design

Manufacturing transfers

Supplier qualification

Root-cause analysis

Process validation

Project management

Documentation

Cross-functional collab

Education

Master's in ME

Bachelor's in ME

Life sciences experience

FDA-regulated exposure

Tools

SolidWorks

GD&T

Job description

Hydrogen Group is seeking a Senior Mechanical Engineer onsite in Hayward, CA to lead supplier-relocation projects for DNA sequencing systems.

You will review drawings, coordinate with suppliers, and drive verification, validation, and qualification activities to ensure design integrity and regulatory compliance throughout transfers. This role demands strong project management and cross-functional collaboration in a regulated manufacturing setting.