Senior Manufacturing Engineer

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

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 ~50%.
• Experience with some mix of Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, Document Management System.