Supplier Engineer 3 - Plastics

Position Summary

The Plastics Consumables Engineer 3 will support internal manufacturing by managing and validating projects, often with suppliers, for new injection molded plastic consumables, assemblies, and related automation systems.

Responsibilities

• Manage injection molded plastic consumables, molded and assembled components, and related automation systems, including finished and semi-finished forms.
• Lead initiatives involving injection molds, tooling, consumables automation, and assembly equipment such as leak testers, robotics, and part-handling or separation systems.
• Lead technical evaluation and qualification of new and existing plastics and consumables suppliers, including process capability, control strategies, and manufacturing readiness.
• Establish validation requirements and develop or approve IQ/OQ/PQ documentation at suppliers for injection molds, associated auxiliary equipment, and automation systems.
• Review supplier process flow, PFMEA, control plans, inspection methods, and validation packages to ensure robust and scalable production.
• Support first article inspection, process qualification, and production acceptance for supplier-manufactured consumables and components.
• Lead defect and failure analysis for molded consumables, including short shots, flash, sink, warpage, dimensional drift, contamination, weld or knit line issues, and cosmetic defects that impact function.
• Develop inspection and measurement techniques, including fixtures, gauges, and metrology approaches for dimensional and functional verification.
• Apply working knowledge of in vitro diagnostic (IVD) products, cGMP and FDA regulatory compliance, and industry guidance initiatives such as MDSAP.
• Continuously improve internal and external supplier processes to reduce time to market, enhance product quality, and decrease costs.
• Support new product development by providing Design for Manufacturing and Design for Assembly feedback on concept and prototype consumables, driving robust, consistent, and manufacturable processes.
• Collaborate with suppliers on prototype development, manufacturability assessments, and process readiness for scale-up.
• Sustain complex cross-functional investigations, perform root cause analysis, and recommend corrective actions for non-conforming events or manufacturing concerns using risk-based methods.
• Initiate and/or review change orders related to suppliers, collaborating with the appropriate departments and personnel.
• Actively manage tooling, molds, fixtures, and process maintenance with suppliers, and monitor performance trends.
• Support supplier quality and process improvements related to dimensional variation, cosmetic condition, fit, function, and long-term process capability.

  Qualifications

  • Education: BA or BS degree, preferred in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or Validation Engineering.
  • Experience: 5-8+ years of Biotech, Medical Device, or Pharmaceutical industry experience.
  • Skills: Plastic and injection molded consumables manufacturing experience, low to high volume; experience working with custom injection molding and consumables automation suppliers and processes such as injection molding, tooling and mold qualification, automated assembly, leak and functional testing, and packaging interfaces; experience with process validation (IQ/OQ/PQ), first article inspection, and measurement systems analysis for molded components; high proficiency with MS Office, MS Project, and MS SharePoint; high proficiency with Minitab or other statistical analysis software; working knowledge of manufacturing automation systems and design practices; working knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR Part 820; working knowledge of engineering drawings, GD&T, tolerance analysis, and inspection methodologies.
  • Travel: Approximately 0-4 times annually, usually less than one week in duration for each occurrence.
  • Compensation: Annualized base salary range for this role is $97,000 to $140,000 and is bonus eligible.
  • EEO: Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.