Senior Manufacturing Engineer: Process & Equipment Innovation

Ortho Clinical Diagnostics; Carlsbad (CA); On-site; USD 105,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Employee stock purchase plan

Paid time off

Paid holidays

Job summary

QuidelOrtho in Carlsbad, CA is seeking a Senior Manufacturing Engineer to provide engineering expertise for new product development, process development, and sustaining engineering. The role is on-site and supports transfer of products from R&D to production while ensuring SI and MI documentation and quality compliance.

Key responsibilities include developing manufacture strategies, maintaining MI’s, documenting SPCs and BOMs, and driving continuous improvement. Travel up to 10% may be required.

Qualifications

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing or Industrial Engineering or 10 years of relevant work experience.
• Minimum 5 years of experience in manufacturing operations.
• Understands GMP and lean manufacturing principles.
• Advanced problem solving skills.
• Excellent verbal and written communication skills.
• This position is not currently eligible for visa sponsorship.

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.

Skills

Problem solving

Communication

GMP knowledge

Education

Engineering degree (Mechanical/Manufacturing/Industrial)

Tools

2D/3D CAD

Process automation

Quality tools

Job description

QuidelOrtho in Carlsbad, CA is seeking a Senior Manufacturing Engineer to provide engineering expertise for new product development, process development, and sustaining engineering. The role is on-site and supports transfer of products from R&D to production while ensuring SI and MI documentation and quality compliance.

Key responsibilities include developing manufacture strategies, maintaining MI’s, documenting SPCs and BOMs, and driving continuous improvement. Travel up to 10% may be required.