Supplier Engineer 3 - Plastics

Hologic•San Diego, CA

17h•$97,000 - $140,000

About The Position

Hologic is a global medical technology company focused on women's health, developing innovative diagnostic, detection, and surgical solutions. The San Diego campus is a center for Diagnostic Solutions, specializing in Molecular Diagnostics. This role supports internal manufacturing by managing and validating projects, often with suppliers, for new injection molded plastic consumables, assemblies, and related automation systems. The projects span from design concept to production acceptance. Responsibilities include supplier process development and validation, technical evaluation, testing, statistical analysis, qualification, and ongoing process improvement, in collaboration with R&D on manufacturing design and design transfer. The position also provides sustaining product support for quality, supply continuity, and cost savings. The role integrates Manufacturing Engineering, Mechanical Engineering, and Supplier Quality Engineering disciplines.

Requirements

BA or BS degree, preferred in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or Validation Engineering.
5-8+ years of Biotech, Medical Device, or Pharmaceutical industry experience.
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.

Nice To Haves

Lean Manufacturing and/or Six Sigma Certification preferred but not required.
Certified Quality Engineer Certification preferred but not required.

Responsibilities

Manage injection molded plastic consumables, molded and assembled components, and related automation systems.
Lead initiatives involving injection molds, tooling, consumables automation, and assembly equipment.
Lead technical evaluation and qualification of new and existing plastics and consumables suppliers.
Establish validation requirements and develop or approve IQ/OQ/PQ documentation at suppliers for injection molds, auxiliary equipment, and automation systems.
Review supplier process flow, PFMEA, control plans, inspection methods, and validation packages.
Support first article inspection, process qualification, and production acceptance for supplier-manufactured consumables and components.
Lead defect and failure analysis for molded consumables.
Develop inspection and measurement techniques, including fixtures, gauges, and metrology approaches.
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 the design transfer process from R&D to Operations.
Partner with R&D early in development to provide Design for Manufacturing and Design for Assembly feedback.
Provide material and process alternatives based on application requirements.
Collaborate with suppliers on prototype development, manufacturability assessments, and process readiness for scale-up.
Support complex cross-functional investigations.
Perform root cause analysis and recommend corrective actions for non-conforming events or manufacturing concerns.
Participate in ideation activities, cause and effect analysis, process variables mapping, and pFMEAs.
Initiate and/or review change orders related to suppliers.
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.