Senior Manufacturing Engineer: Process & Equipment

RXinsider LTD.; Carlsbad, Northern (CA, KY); Hybrid; USD 105,000 - 115,000; Full time

Job summary

QuidelOrtho in Carlsbad, CA is seeking a Senior Manufacturing Engineer to drive transfer from R&D to production and optimize manufacturing processes. You will develop equipment strategies, maintain manufacturing instructions, and support capital equipment procurement while ensuring quality and compliance with GMP and lean principles.

The role is on-site, with collaboration across R&D, Production, Quality, and Planning teams, requiring strong problem-solving and communication skills.

Qualifications

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing or Industrial.
• Minimum 5 years of experience in manufacturing operations.
• Understanding of GMP and lean manufacturing principles.

Responsibilities

• Develops manufacturing strategies to support the transfer of products from R&D to production and ensures product specifications are consistent with standard raw materials and manufacturing processes.
• Maintains integrity of manufacturing instructions (MI’s).
• Develops, maintains and approves manufacturing instructions, SPC, routings and BOM’s and manufacturing documentation for new and existing products and processes.
• Processes yields and scrap.
• Performs analysis, testing and qualification as required to support raw material and part configuration changes, and performs process improvement troubleshooting activities.
• Generates equipment specifications defining machine performance criteria that are quantifiable by SPC and FEMA analysis.
• Develops new equipment strategies and generates documentation to support procurement of capital equipment including conducting financial analysis.
• Develops manufacturing control plans and metrics that verify machine outputs are compliant with QSR standards.
• Supports machine build activity through regular design reviews and milestones.
• Installs and validates existing and new equipment, generate equipment operating instructions and conducts operator and maintenance training.
• Applies engineering techniques to sustain and maximize current manufacturing efficiencies. Areas include: wet chemistry processing and filling, automated and manual assembly.
• Identifies and implement new technologies and continuous improvement to optimize manufacturing process output.
• Identifies process control points and implements appropriate process control parameters.
• Provides engineering guidance for cross-functional project teams.
• Leads and organizes complex manufacturing projects
• Generates project plans and timelines
• Organizes and manages team meetings, generates agendas and writes meeting minutes.
• Generates documentation for production operations including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans.
• Maintains and generates new item information and routings per ERP requirements.
• Submits documents and create ECO’s for any new and existing product and processes per document control guidelines.
• Develops and maintains budgets for multi-tasked projects and conducts the financial analysis necessary to justify procurement of new capital equipment and supports the development of contractual agreements that incorporate supplier accountability for cost, schedule, and quality.
• Carries out duties in compliance with established policies.
• Performs additional work related duties as assigned.

Skills

GMP knowledge

Lean manufacturing

Problem solving

Strong communication

Education

BS in Engineering (Mechanical/Manufacturing/Industrial)

Tools

2D CAD

3D CAD

Electrical-mechanical theory

Hardware design

Pneumatics

Instrumentation

Job description

QuidelOrtho in Carlsbad, CA is seeking a Senior Manufacturing Engineer to drive transfer from R&D to production and optimize manufacturing processes. You will develop equipment strategies, maintain manufacturing instructions, and support capital equipment procurement while ensuring quality and compliance with GMP and lean principles.

The role is on-site, with collaboration across R&D, Production, Quality, and Planning teams, requiring strong problem-solving and communication skills.