Sr. Manufacturing Engineer Three Point Solutions, Inc.

• 4.4 Northridge, CA Job Details Full-time | Contract $75
• $80 an hour 1 day ago Qualifications Statistics Operational analysis Defect resolution root cause analysis Machine design Engineering development testing Quality control statistical data analysis Engineering process optimization Project management experience in manufacturing Technical support Manufacturing facility experience Statistical analysis Production validation processes Bachelor's degree Medical device manufacturing facility experience Technology transfer (scale-up process) Regulatory/legal compliance standards in production Collaboration with manufacturing teams Biomedical regulatory compliance Operational excellence initiatives Manufacturing engineering Test validation method Legal compliance FDA regulations Failure analysis Engineering manufacturing support Full Job Description Job title : Sr.

Manufacturing Engineer Client :

Medical Device Manufacturing company

Duration :

12 months with a possibility for extension

Location :

San Diego, CA or Northridge, CA Shift :

1 st shift Job Overview The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement. The role focuses on achieving yield, capacity, throughput, reliability, and quality goals by driving the development, validation, implementation, and optimization of manufacturing processes. The Senior Manufacturing Engineer partners with internal and external stakeholders to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability.

Key Responsibilities:

Manufacturing Process Engineering Design manufacturing processes, procedures, and production layouts for semi-automated equipment installation, processing, and material handling. Adapt machine and equipment designs to factory and production conditions. Incorporate inspection and testing requirements into production plans. Develop and maintain manufacturing process specifications, work instructions, and engineering documentation. Provide engineering guidance on design concepts and specification requirements to optimize equipment and manufacturing techniques.

Equipment & Process Validation:

Develop and execute equipment and process validation activities.

Create and execute:

IQ

• Installation Qualification ,
• OQ•Operational Qualification ,•PQ•Performance Qualification Develop and validate test methods.

Inspect machinery, equipment, and tools to verify efficiency and performance. Investigate equipment/process deficiencies and implement corrective actions.

Automation & Advanced Manufacturing:

Supported automation initiatives and advanced manufacturing technologies. Partnered with equipment suppliers and internal stakeholders to improve equipment capability and reliability. Supported equipment readiness and manufacturing scale-up.

Quality & Problem Solving:

Served as the primary technical escalation point for complex manufacturing and quality issues. Lead Root Cause Investigations using structured problem-solving methodologies, including: 5 Why,Fishbone Analysis ,Statistical Analysis Ensure manufacturing processes meet applicable quality and regulatory requirements.

Continuous Improvement & Manufacturing Performance:

Lead initiatives to: Improve yield , Reduce scrap , Increase throughput ,

• Optimize labor utilization , Improve manufacturing reliability ,
• Develop manufacturing strategies for commercial production ramp-up,Identify and eliminate production bottlenecks impacting manufacturing performance,Drive continuous improvement of manufacturing processes and equipment.

Regulatory Compliance:

Ensure manufacturing processes and procedures comply with: FDA Quality System Regulations (QSR),ISO 13485,Company procedures and quality requirements

Required Qualifications:

Bachelor's degree or equivalent qualifying foreign degree with: 4+ years of relevant experience, OR Advanced degree with: 2+ years of relevant experience,Advanced knowledge of manufacturing engineering principles,Practical knowledge of project management.

Required Technical Experience:

Experience supporting medical device manufacturing operations.

Strong understanding of:

Manufacturing Process Validation,Equipment Qualification,IQ / OQ / PQ,Test Method Validation,Statistical Analysis,Process Control Methodologies,Root Cause Analysis,Continuous Improvement,Semi-Automated Manufacturing Equipment Experience with manufacturing process optimization and equipment reliability. Ability to work with internal teams and equipment suppliers. Ability to support manufacturing ramp-up and resolve complex technical issues. Travel Requirement Approximately 50% travel required. IND_

ENG Pay:

$75.00

• $80.

00 per hour

Education:

Bachelor's (Required)

Experience:

Medical Device/Pharma/FDA-Regulated:

5 years (Required) Manufacturing engineering: 5 years (Required)

IQ/OQ/PQ

5 years (Required) Ability to

Commute:

Northridge, CA 91325 (Required) Willingness to travel: 50% (Required)

Work Location:

In person