About this opportunity
Nova Pneuma, Inc. lists this Product & Process Industrialization Engineer opportunity in iowa, Louisiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.
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Worksite address
iowa, LA, 70647, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.