Senior Plastics Consumables Engineer

Hologic, Inc.; San Diego (CA); On-site; USD 97,000 - 140,000; Full time

Job summary

Hologic, Inc. in San Diego focuses on Molecular Diagnostics and innovative medical technology. The Plastics Consumables Engineer 3 will support internal manufacturing by managing projects with suppliers for injection molded consumables and related automation systems, from concept to production acceptance.

You will lead process validation, supplier qualification, PFMEA reviews, and continuous improvement, partnering with R&D and Quality to ensure quality, supply continuity, and cost savings.

Qualifications

• 5–8+ years in Biotech/Medical Device/Pharma industries.
• Experience with plastic injection molded consumables manufacturing.
• Knowledge of IQ/OQ/PQ, first article inspection, and measurement systems analysis.

Responsibilities

• Manage injection molded plastic consumables, molded and assembled components, and related automation systems, including finished and semi-finished forms.
• Lead supplier qualification and validation activities, including process capability and manufacturing readiness.
• Develop validation requirements and documentation (IQ/OQ/PQ) with suppliers for molds and automation equipment.
• Support design transfer from R&D to Operations, defining consumable and component requirements.
• Collaborate with suppliers on prototype development and scale‑up readiness.

Skills

Biotech experience

Medical device

Quality engineering

Process validation

Statistical analysis

MS Office

MS Project

MS SharePoint

Education

BS in Manufacturing/Mechanical/Industrial/Quality/Validation Engineering

Tools

Minitab

MS Office

MS Project

MS SharePoint

Job description

Hologic, Inc. in San Diego focuses on Molecular Diagnostics and innovative medical technology. The Plastics Consumables Engineer 3 will support internal manufacturing by managing projects with suppliers for injection molded consumables and related automation systems, from concept to production acceptance.

You will lead process validation, supplier qualification, PFMEA reviews, and continuous improvement, partnering with R&D and Quality to ensure quality, supply continuity, and cost savings.