SENIOR MECHANICAL ENGINEER

LOCATION: Hayward, CA (Onsite)

SCHEDULE: Monday–Friday, 8:00 AM–5:00 PM

DURATION: 14-Month Contract

PAY: 63-68 USD per hour

Job Responsibilities:

In this role, you will lead engineering activities to qualify supplier relocations for DNA sequencing systems. You will ensure that mechanical components, assemblies, and manufacturing processes continue to meet the required design, quality, reliability, and performance standards when production moves to a new supplier or manufacturing location.

Key responsibilities include:

• Leading supplier-relocation projects and developing qualification plans, requirements, schedules, budgets, and risk assessments.
• Reviewing engineering drawings, specifications, bills of materials (BOMs), manufacturing processes, tooling, and inspection methods.
• Working with suppliers to collect technical documentation, samples, inspection records, material certifications, and validation evidence.
• Developing and executing verification and validation plans, dimensional inspections, functional testing, and process-capability studies.
• Identifying and resolving supplier quality issues, qualification failures, and manufacturing-related problems.
• Collaborating with Quality, Manufacturing, Supply Chain, Regulatory, and Process Engineering teams to obtain necessary approvals.
• Managing engineering change control, supplier approvals, documentation updates, and release-to-manufacturing activities.
• Maintaining accurate qualification records and ensuring projects meet established timelines and budgets.

Essential Duties and Job Functions:

• Assess the technical requirements involved in transferring manufacturing from one supplier or location to another.
• Evaluate mechanical parts, assemblies, materials, and manufacturing processes to identify potential risks and technical gaps.
• Review engineering drawings and apply Geometric Dimensioning and Tolerancing (GD&T) principles to ensure components meet design specifications.
• Develop qualification requirements based on product performance, material properties, dimensional tolerances, and manufacturing capabilities.
• Coordinate with suppliers to obtain qualification samples, material certifications, inspection results, and supporting documentation.
• Plan and conduct verification and validation activities to confirm that relocated parts and processes meet established requirements.
• Perform or coordinate dimensional and functional testing, measurement-system analysis, and process-capability studies.
• Lead root-cause analysis and corrective actions for failed qualifications, supplier deviations, and technical issues.
• Review qualification results with internal stakeholders and secure the required technical and quality approvals.
• Manage engineering changes, supplier qualification documentation, part approvals, and lifecycle-management reviews.
• Ensure qualified components and manufacturing processes are approved and ready for production.
• Track project progress, manage competing priorities, communicate risks, and implement recovery plans when necessary.
• Prepare clear technical reports and maintain complete, accurate engineering records.

Knowledge & Skills:

• Strong knowledge of mechanical engineering principles, mechanical design, and precision assemblies.
• Proficiency in SolidWorks, engineering drawings, and GD&T.
• Understanding of materials, manufacturing methods, fabrication processes, tooling, and inspection techniques.
• Knowledge of supplier qualification, manufacturing transfers, sustaining engineering, and verification and validation.
• Ability to evaluate dimensional variation, material properties, and process capability in relation to product performance.
• Experience with root-cause analysis, problem-solving, and corrective and preventive actions.
• Familiarity with measurement-system analysis, dimensional inspection, functional testing, and process-capability studies.
• Strong project management skills, including scheduling, risk management, budgeting, and documentation.
• Excellent written, verbal, and technical communication skills.
• Ability to work effectively with suppliers and cross-functional engineering, quality, manufacturing, and supply chain teams.
• Strong analytical skills and attention to detail.
• Ability to independently manage multiple supplier-relocation projects and meet critical deadlines.
• Familiarity with regulated manufacturing environments and engineering change-control processes.

Education & Experience:

• Master's degree in Mechanical Engineering with at least 5 years of relevant experience, or
• Bachelor's degree in Mechanical Engineering with at least 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.

...