Senior Manufacturing Engineer - Process Validation

Redbock - an NES Fircroft company; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Redbock - an NES Fircroft company seeks a Senior Manufacturing Engineer to own and optimize medical device manufacturing processes. You will drive process validations, equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality goals.

You will collaborate with internal and external teams, lead root-cause analyses, and ensure compliance with FDA QSR and ISO 13485 guidelines while advancing automation and lean initiatives.

Qualifications

• Baccalaureate degree and 4+ years of relevant experience in medical device manufacturing.
• Experience with automated and semi-automated equipment.
• Strong knowledge of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control.
• Willingness to travel up to 50%.

Responsibilities

• Designs manufacturing processes and production layouts for semi-automation equipment installation and handling.
• Adapts equipment design to factory conditions and integrates inspection requirements into production plans.
• Leads root cause investigations using 5 Why, Fishbone, and statistical analysis.
• Develops and maintains process specifications, work instructions, and documentation.
• Supports automation initiatives and ensures compliance with FDA QSR and ISO 13485.

Skills

Manufacturing process validation

Statistical analysis

Root cause analysis

Cross-functional collaboration

Project management

Education

Bachelor's degree in engineering

Master's degree (preferred)

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Document Management System

Job description

Redbock - an NES Fircroft company seeks a Senior Manufacturing Engineer to own and optimize medical device manufacturing processes. You will drive process validations, equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality goals.

You will collaborate with internal and external teams, lead root-cause analyses, and ensure compliance with FDA QSR and ISO 13485 guidelines while advancing automation and lean initiatives.