Product & Process Industrialization Engineer

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
• Own supplier-side deliverables during scale-up
• 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 (https://www.eeoc.gov/poster) notice from the Department of Labor.