***W2 ONLY, C2C candidates, or Candidates with the following Visa Status will not be accepted: H1B, OPT, OPT-STEM**
Technical Lead, Manufacturing (12 month contract // Northridge or San Diego, CA):
Top Required Skills:
- Manufacturing process engineering and production optimization
- Process validation/TMV and equipment qualification
- Medical device manufacturing with FDA/ISO 13485 compliance, including FDA Quality System Regulations, ISO 13485, change control, risk management, and quality requirements.
- Continuous improvement, OEE/yield/capacity analysis, and technical problem solving
- NPI, technology transfer, manufacturing scale-up, and capital equipment/automation projects
Education: Bachelor’s Degree in Engineering, ideally Mechanical, Biomedical, Electrical, or Chemical Engineering
Target Years of Experience: Seeking 8-10+ years of experience in manufacturing and leadership
Description:
Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations. This role serves as the primary engineering lead responsible for process validations, process performance, equipment reliability, product quality, capacity expansion, and continuous improvement initiatives. They collaborate cross-functionally with Operations, Quality, Supply Chain, Research & Development, Regulatory Affairs, and Manufacturing Engineering teams to support commercial production, new product introductions, and operational excellence objectives.
Duties:
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- Adapts machine or equipment design to factory and production conditions.
- May 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 manufacturing processes that are applicable to statistical process control and may develop those techniques.
- Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
- Ensures processes and procedures follow regulations.
- Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.
- Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
- Identify and mitigate technical risks impacting safety, quality, delivery, or manufacturing continuity.
- Support new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up.
- Provide technical oversight for capital equipment projects, automation initiatives, and facility upgrades.
- Analyze and report manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).
- Serve as the primary technical escalation point and owner for technical strategy, operational performance, product launch, and hypercare of the manufacturing line.
- Mentor and guide manufacturing engineers, process engineers, and cross-functional team members
Must Haves:
- Experience with NPI, technology transfer, manufacturing scale-up, and capital equipment/automation projects.
- Experience with project/program management, ideally for commercialization and NPI projects.
- Experience with semi-automated manufacturing equipment and assembly systems, PLC-controlled equipment and machine interfaces, and vision inspection systems.
- Experience with welding plastic injection molded parts.
- Experience with OEE analysis, Capacity Planning, Yield Improvement, and Scrap Reduction.
- Experience with Process Validation, Test Method Validation, Change Control management.
- Experience with Statistical Analysis, ideally with Minitab.
- Experience with disposition of NCRs, structured problem-solving (i.e., Root Cause Analysis), and CAPAs.
- Experience with technical decision making, project planning and execution to goals, and resource prioritization.
- Experience with a mix of these software systems: Microsoft Office, SAP, MES, AutoCAD, SolidWorks, Minitab, Document Management System
