Supplier Engineer 3 - Plastics

Hologic is one of the world's most innovative medical technology companies and a global champion of women's health. We advance diagnostic, detection, and surgical solutions that respond to an increasingly complex and demanding global healthcare environment. What powers our growth is also what differentiates us: the exceptional, clinically proven ability of our products to detect, diagnose, and treat illnesses and other health conditions earlier and better.

Our commitment to better outcomes for patients, healthcare professionals, and health systems creates high expectations, which we fulfill by relentlessly focusing on the delivery of leading-edge technology that can change the trajectory of diagnoses, treatments, and lives. Together, we advocate for better health and well-being through solutions that provide ever greater certainty and peace of mind.

The San Diego Campus is the center of our Diagnostic Solutions. With a focus on Molecular Diagnostics, the majority of products produced from the San Diego site are utilized onboard innovative and fully automated sample-to-result instrument systems. The consumables required for patient testing are integral to our business. The business growth projections and new product development projects provide unique opportunities to enable our purpose, passion and promise to empower global health advancements.

The Plastics Consumables Engineer 3 will be an essential team member supporting internal manufacturing by managing and validating projects, often with suppliers, for new injection molded plastic consumables, assemblies, and related automation systems. Projects begin at design concept and conclude with production acceptance. Responsibilities include supplier process development and validation, technical evaluation, testing, statistical analysis, qualification, and ongoing process improvement, working in close partnership with R&D on manufacturing design and design transfer.

This position also involves sustaining product support to ensure quality products, continuity of supply, and cost savings initiatives. The role incorporates various engineering disciplines, including Manufacturing Engineering, Mechanical Engineering, and Supplier Quality Engineering.

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Manage injection molded plastic consumables, molded and assembled components, and related automation systems, including finished and semi-finished forms.
• Lead initiatives that may involve 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 the design transfer process from R&D to Operations, which may include defining consumable and component requirements, qualifying molded parts and assemblies, labeling, and establishing supplier manufacturing methods.
• Partner with R&D early in development to provide Design for Manufacturing and Design for Assembly feedback on concept and prototype consumables, driving robust, consistent, and manufacturable processes.
• Provide material and process alternatives based on application requirements, including tooling and gating strategy, molding process window, assembly method, and cosmetic and functional requirements, in partnership with R&D and Quality.
• 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…