Equipment Engineer – Medical Device Manufacturing & Automation

QuidelOrtho Corporation; Carlsbad (CA); On-site; USD 89,000 - 102,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Paid time off

Job summary

QuidelOrtho Corporation in Carlsbad, CA is seeking an Equipment Engineer to advance new product development, process improvement, and sustaining engineering on manufacturing lines. The role involves selecting and integrating equipment, leading capital projects, writing validation and control documentation, and collaborating with R&D, Quality, and Operations to meet quality standards and schedule.

Onsite work required.

Qualifications

• BS degree in Mechanical, Manufacturing, or Industrial Engineering.
• 3 years in pharma/medical device manufacturing environment.
• Subject matter expert on at least one equipment or process with understanding of cGMP and lean manufacturing.

Responsibilities

• Select, install, diagnose and operate manufacturing equipment and lines.
• Lead moderately sized capital equipment projects with vendors.
• Write and review documentation for production operations (validation protocols, design control, pFMEA, control plans).
• Develop manufacturing control plans and metrics to verify compliance with QSR standards.
• Create and maintain SOPs, work instructions, BOMs, and routings; train on new procedures.
• Analyze measurement, machine, process and product data with basic statistics.
• Monitor and improve yield, scrap, OEE and throughput.
• Identify and implement new technologies and continuous improvements.
• Collaborate with R&D, Quality, Operations, Supply Chain and partners for projects and problem-solving.
• Support or lead audits, CAPA investigations, NCR resolution, and change control activities.
• Organize meetings, generate agendas, and write minutes.
• Develop and manage budgets for multi-tasked projects and procurement of capital equipment; contract agreements with suppliers.
• Interpret CAD models and drawings; modify components as needed.

Skills

Problem solving

Communication

Lean manufacturing

GMP knowledge

Education

BS degree in Mechanical/Manufacturing/Industrial Engineering

Tools

CAD (2D/3D)

Electrical wiring

Pneumatics

Job description

QuidelOrtho Corporation in Carlsbad, CA is seeking an Equipment Engineer to advance new product development, process improvement, and sustaining engineering on manufacturing lines. The role involves selecting and integrating equipment, leading capital projects, writing validation and control documentation, and collaborating with R&D, Quality, and Operations to meet quality standards and schedule.

Onsite work required.