Technical Lead

This role provides technical leadership and operational oversight for commercial medical device manufacturing operations and new product introduction activities. The Technical Lead serves as the primary engineering owner for manufacturing line performance, process validations, equipment reliability, product quality, capacity expansion, automation initiatives, and continuous improvement. The position partners closely with Operations, Quality, Supply Chain, Regulatory Affairs, R&D, and Manufacturing Engineering to support production goals, manufacturing scale-up, product launches, and operational excellence initiatives, while mentoring engineers and driving strategic manufacturing improvements. Responsibilities

• Serve as the primary technical owner of the manufacturing line, ensuring stable, efficient, and compliant operations.
• Lead process validations and equipment qualifications to ensure robust, capable, and compliant manufacturing processes.
• Manage manufacturing change implementation, including change control activities and documentation.
• Drive the technical strategy that supports safety, quality, delivery, and manufacturing continuity across the line.
• Support new product introductions by leading process development, technology transfer, line readiness, and production scale-up activities.
• Provide technical leadership for capital equipment projects, automation initiatives, and facility upgrades.
• Design and optimize manufacturing processes, line layouts, equipment installations, and material handling systems to improve flow and efficiency.
• Develop and improve manufacturing processes using statistical process control (SPC) methodologies.
• Investigate equipment and process issues, perform root cause analysis, and implement corrective and preventive actions to enhance product quality and operational performance.
• Analyze manufacturing metrics such as yield, capacity, labor utilization, and overall equipment effectiveness (OEE) to identify and drive improvement opportunities.
• Identify technical risks associated with processes, equipment, and new products, and develop mitigation strategies.
• Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations and applicable ISO requirements.
• Serve as the primary escalation point for manufacturing performance issues and product launch support needs.
• Mentor and guide manufacturing engineers, process engineers, and cross-functional team members, fostering technical development and best practices.
• Lead cross-functional technical initiatives that support manufacturing strategy, continuous improvement, and long-term operational excellence., Machining Construction Health Advocacy Business Solutions Discounts And Allowances Employee Assistance Programs +0 Assistant Engineer Actalent

Valencia, CA*Remote

Visionary Innovation Mathematics Communication CADD Software Detail Oriented Quality Control Land Development Quality Assurance Civil Engineering Quality Management Grading (Landscape) Time Off Management Engineer in Training Project Documentation Organizational Skills Computer-Aided Design Stormwater Management Engineering Practices Civil Engineering Design Engineering Design Process Engineering Plans And Specifications +0

Timelines Visionary Operations Leadership Automation Mentorship Innovation Mitigation Reliability Supply Chain Change Control Decision Making Design Analysis SAP Applications Material Handling Capacity Planning Regulatory Affairs Process Validation Technical Strategy Root Cause Analysis Process Development Technology Transfer Technical Leadership Technological Change Strategy Development Operational Excellence Project Implementation New Product Development Manufacturing Processes Product Quality (QA/QC) Manufacturing Engineering Quality Management Systems Engineering Design Process Statistical Process Controls Medical Device Manufacturing Continuous Improvement Process Enterprise Application Software Overall Equipment Effectiveness Corrective And Preventive Action (CAPA), * Bachelor’s degree in Engineering or a related technical discipline.

• Minimum 7 years of relevant manufacturing engineering experience; an advanced degree with 5+ years of experience may be considered.
• Proven experience supporting medical device manufacturing operations.
• Strong background in process validation, including protocol development, execution, and reporting.
• Demonstrated experience in equipment qualification and manufacturing change control.
• Hands-on experience with semi-automated manufacturing equipment and assembly systems.
• Knowledge of PLC-controlled equipment and machine interfaces.
• Experience with vision inspection systems and automated manufacturing equipment.
• Strong understanding of OEE analysis, capacity planning, yield improvement, and scrap reduction.
• Proficiency in root cause analysis methodologies and structured problem-solving.
• Ability to lead technical decision-making, project execution, and cross-functional initiatives.
• Experience mentoring engineers and providing technical leadership in a manufacturing environment.
• Manufacturing engineering experience in a regulated environment, with familiarity in FDA Quality System Regulations and ISO requirements.
• Experience with SAP or similar enterprise systems for manufacturing or operations.
• Demonstrated capability in continuous improvement within manufacturing operations.

Additional Skills & Qualifications

• Experience with new product introduction (NPI) and manufacturing scale-up activities.
• background in medical device manufacturing, including understanding of regulatory and quality expectations.
• Experience with automation projects, including PLC systems and vision inspection systems integration.
• Exposure to capital equipment planning, selection, installation, and validation.
• Experience with statistical process control (SPC) and data-driven process optimization.
• Demonstrated success in yield improvement, capacity planning, and scrap reduction initiatives.
• Technical project leadership experience, including managing timelines, risks, and cross-functional coordination.
• Experience with technology transfer from R&D or pilot lines into full-scale manufacturing.
• Familiarity with manufacturing strategy development and implementation.
• Comfort working with large-scale enterprise systems such as SAP for production and materials management., Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.