Product & Process Industrialization Engineer

Product & Process Industrialization Engineer

Job Category : Process Engineers

Requisition Number : PRODU

• Posted : September 29, 2026
• Full-Time

Locations

Showing 1 location

6550 Dumbarton Cir
Fremont, CA 94555, USA

Description

Job Summary

Bridges the gap between R&D and mass production, optimizing manufacturing processes, supplier quality, and cost-efficiency. They lead product ramp-ups, conduct Design for Manufacturing (DFM) analyses, audit suppliers, and ensure high-quality, high-yield production.

Responsibilities

• Technical SME and support for external suppliers ensuring alignment with product requirements
• Ensure supplier readiness for pilot builds, commercial scale-up and capacity expansion
• Drive timelines aligned to product launch milestones
• Define and ensure validation strategy at suppliers for equipment (IQ/OQ/PQ) and support process performance validation
• Support or lead internal process or equipment validation efforts
• Draft, review and approve protocols and reports
• Assess supplier technical capability
• Evaluation impact of supplier change requests, process improvements and raw material substitution
• Perform on-site technical reviews and gap assessments
• Lead process FMEA and risk mitigation with supplier teams
• Ensure traceability from design inputs to production controls
• Draft, review and approve protocols and reports
• Analyze yield, scrap and defect
• Review deviation investigations and CAPAs impacting product
• Identify process optimization opportunities
• Evaluate second-source suppliers for risk mitigation and assist with site transfers and line expansion
• Author technical justification for change controls and supplier RFC as required

Skills required

• Excellent mechanical aptitude and good attention to details
• Experience designing and troubleshooting electronic and mechanical systems
• Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
• Experience in numerical modeling including CFD
• Experience in statistical analysis, including use of tools such as JMP for data analysis and experimental design
• Experience in designing injection molded parts preferred
• Excellent oral and written communication skills as well as strong interpersonal skills
• Experience programming in LabVIEW a plus
• Well versed in medical device regulatory requirements from Food and Drug Administration (FDA), European Medicines Agency (EMA), etc. and regulatory standards
• Experience working in compliance with GMP and GDP regulations

Education and experience

• Bachelor’s degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalent
• Master’s or higher-level degree in Engineering, Physics or related field, or demonstrated equivalent experience.
• 10-15 years of experience in design/development/troubleshooting of medical devices and/or electromechanical systems
• Strong cross-functional leadership, communication, project management, and ability to work under tight deadlines

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel

Equal Opportunity Employer
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