Senior Manufacturing Engineer

Redbock - an NES Fircroft company; San Fernando (CA); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Restaurant nearby

Job summary

Redbock - an NES Fircroft company is seeking a Sr. Manufacturing Engineer for a 12-month contract in Northridge, CA. The role focuses on process validations, equipment readiness, and continuous improvement to meet yield and quality goals.

The ideal candidate will design and optimize manufacturing processes, support automation initiatives, and lead root cause investigations. Travel up to 5-10% may be required; FDA QSR and ISO 13485 compliance is essential.

Qualifications

• Requires knowledge of medical device manufacturing operations and validation.
• Lean/Six Sigma experience preferred for process improvement.
• Experience with problem solving tools (e.g., 5 Why, Fishbone, RCA) and statistics.

Responsibilities

• Design manufacturing processes, procedures and layouts for semi-automation equipment installation and handling.
• Adapt equipment design to production conditions and incorporate inspection/test requirements.
• Inspect machinery performance and initiate corrective actions to ensure product quality.
• Develop and maintain manufacturing process specs, work instructions and engineering docs.
• Provide guidance on design concepts and specification requirements to optimize equipment use.
• Develop and execute IQ/OQ/PQ validation protocols and test methods.
• Support automation initiatives and advanced manufacturing technologies.
• Serve as escalation point for complex manufacturing and quality issues.
• Lead root cause investigations using structured problem solving.
• Lead yield improvement, scrap reduction, throughput increase, and labor optimization.
• Collaborate with suppliers and internal teams to improve capability and reliability.
• Develop strategies for commercial ramp-up and bottleneck removal.
• Ensure processes follow FDA QSR, ISO 13485, and company procedures.

Skills

Medical device manuf.

Lean/Six Sigma

Process design & optimization

Root cause analysis

Education

Bachelor's degree

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Job description

Sr. Manufacturing Engineer (12 month contract, strong potential for conversion // Northridge, CA):

Top Required Skills:

• Experience with medical device manufacturing line implementation and validation, ideally with automated and semi-automated equipment.
• Experience with process improvement methodologies, such as Lean/Six Sigma.
• Experience designing and optimizing manufacturing processes, equipment, layouts, material handling, and production workflows.
• Experience with assessment of NCRs/quality issues using problem solving tools (i.e., 5 Why, Fishbone Analysis, and Statistical Analysis) and RCA.

Description:

The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement activities to meet the yield, capacity, throughput, reliability, and quality goals. This role drives the development, validation, implementation, and optimization of manufacturing processes to ensure product quality, regulatory compliance, operational excellence, and successful commercialization. This role partners closely with internal and external stakeholder teams to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability.

Duties:

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing, and material handling.
• Adapts machine or equipment design to factory and production conditions, incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops and maintains manufacturing process specifications, work instructions, and engineering documentation.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation.
• Supports automation initiatives and advanced manufacturing technologies.
• Serve as the primary technical escalation point for complex manufacturing and quality issues.
• Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
• Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
• Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
• Develop manufacturing strategies for commercial production ramp-up, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures follow FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Must Haves:

• May have practical knowledge of project management.
• Requires a Baccalaureate degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Experience supporting medical device manufacturing operations, ideally with automated and semi-automated equipment.
• Strong understanding of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control methodologies.
• Able to travel up to 5-10%
• Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, Document Management System.