Irvine, CA, United States
19 days ago
Technician Specialist

Position Summary
The Technician Specialist provides technical support and maintenance for production equipment and automation systems used in the manufacturing of medical devices. Responsibilities include troubleshooting and maintaining semi-automated and fully automated equipment used for mixing, dispensing, and packaging biochemical components and products.

Responsibilities

The Technician Specialist will support all manufacturing processes by:

Maintaining and upgrading semi-automated and fully automated equipment. Designing and selecting component modifications, preparing estimates, and executing timely installations. Conducting equipment commissioning, validation, and technical input for manufacturing procedures. Supporting testing procedures, failure investigations, and implementing corrective/preventive actions. Introducing and implementing new manufacturing technologies. Resolving technical challenges in daily manufacturing and operations. Assisting with technology transfers to international or external manufacturing sites. Driving continuous improvement initiatives using Lean/Six Sigma, DFM, SPC, and similar methodologies. Adhering to domestic and international regulatory standards (e.g., GMP, ISO 13485).

Duties and Responsibilities

Under limited supervision and in accordance with applicable laws and policies, the Technician Specialist will:

Troubleshoot, repair, maintain, and upgrade various complex manufacturing equipment, including electro-mechanical test equipment, automated assembly, liquid dispensing, Blow/Fill/Seal systems, labeling, over-wrapping, laser marking, and ultrasonic welding systems. Perform preventive maintenance and ensure timely documentation. Research and recommend supplier parts, submitting purchase orders to ensure equipment uptime and performance. Assist with engineering validations, verifications, and test protocols. Maintain the manufacturing engineering lab and spare parts inventory. Generate and seek approval for Change Orders to update manufacturing documentation. Work independently to prioritize tasks based on business needs and risk. Support and contribute to Process Failure Mode and Effects Analyses (PFMEA). Provide technical support to external suppliers and partners. Maintain training records and comply with safety and manufacturing procedures. Provide input on Job Safety Analysis, Preventive Maintenance Procedures, and Tool Verification Procedures. Perform other duties as assigned, including after-hours or weekend work as required.

Qualifications

Education

Associate degree required. Preferred: Associate degree in Electrical or Mechanical Engineering or equivalent experience.

Experience

Minimum of 3 years troubleshooting and maintaining automated machinery. Minimum of 5 years in a manufacturing environment, preferably medical devices. Preferred experience with semi-automated/fully automated equipment, robotics, and HMIs.

Skills and Abilities

Expertise in troubleshooting electro-mechanical manufacturing processes. Knowledge of Numatics, Fluid Power, and Electrical/Mechanical hardware. Familiarity with PLC codes, I/Os, Servo motors/drives, vision systems, and robotics. Proficiency in CAD software, such as SolidWorks. Strong verbal and written communication skills for effective teamwork. Familiarity with regulatory standards like ISO 13485, GMP, or FDA requirements is desirable.

Preferred Tools and Certifications

Microsoft Office Suite and SolidWorks. Experience with cGMP-based process and equipment validations.

Responsibility for Others and Collaboration

Internal Interactions

Collaboration with cross-functional teams such as Facilities, Quality Engineering, Procurement, Microbiology, Chemistry Labs, and Warehousing.

External Interactions

Engaging with equipment/tool manufacturers and part suppliers (~5% of the time). Potential interactions with government agencies during audits.

Physical Requirements

Standing: Up to 60% Sitting: Up to 90% Walking: 10-20% Kneeling: 0-10%

Work Environment

Controlled environment room gowning may be required.


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Fortive Corporation Overview


Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.


We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.


We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.


At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.


At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.


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