Manufacturing Tech III
Johnson & Johnson
2 months ago
On-site
Santa Clara, CA
Operations
Manufacturing Technician III is responsible for advanced electro-mechanical assembly of robotic modules and components, supporting production schedules, and maintaining compliance with medical device regulations (reports into Surgical Robotics (OTTAVA) Manufacturing).
Key Responsibilities
- Perform advanced electro-mechanical assembly and system-level integration of robotic modules (joints, control modules, sensors, cable harnesses) using work instructions and engineering documentation.
- Meet daily build targets in a structured production environment while complying with ISO 13485, FDA QSR, and GDP.
- Interpret and apply assembly procedures, MPIs, TPIs, and engineering documents to build, verify, and validate components across multiple product modules.
- Conduct functional, electrical, mechanical, and diagnostic testing using calibrated equipment and test procedures.
- Troubleshoot, diagnose, and rework complex electrical/mechanical issues; escalate systemic issues to engineering.
- Maintain compliance with ESD protection, clean manufacturing protocols, and contamination control standards.
- Document production, inspection, rework, and testing results in MES, ERP/SAP, and electronic DHR systems per GDP/GMP.
- Perform in-process inspections and support quality verifications.
- Participate in quality improvement initiatives (including investigations and CAPA support).
- Collaborate with Manufacturing leadership, NPI engineering, Quality, and Operations to support pilot builds and introductions.
- Provide feedback to engineering to improve MWI/MPI/TPI.
- Support training and on-the-job guidance for Technician I/II.
- Maintain certification and multi-module proficiency across at least five major robotic system modules.
- Prepare production lines (line clearance; verify equipment maintenance/calibration).
- Maintain material transaction accuracy and perform cycle counts for inventory.
- Report material shortages/discrepancies to prevent build interruptions.
- Identify workflow bottlenecks and support process efficiency improvements.
Qualifications
Education
- Vocational certificate, technical, or associate degree (or equivalent) required.
Required
- 4–5 years in medical device or electromechanical capital equipment manufacturing, with demonstrated GDP use in a regulated environment.
- Strong mechanical aptitude; ability to troubleshoot and support root cause investigations.
- Electrical troubleshooting proficiency (e.g., multimeters, grounding/isolation, diagnostic evaluation).
- Ability to complete multiple assembly/testing tasks while meeting workmanship, safety, and productivity expectations.
- Knowledge of ESD principles and hands-on ESD controls.
- Proficiency with precision assembly tools (torque wrenches, screwdrivers, calipers, tweezers, multimeters, presses, IPA, adhesives such as Loctite).
- Familiarity with ISO 13485, FDA QSR, and clean manufacturing practices.
- Effective communication/collaboration across manufacturing, engineering, quality, and operations.
- Ability to work independently in a fast-paced environment.
- Flexibility for overtime, early shifts, and weekends.
- Initiative and commitment to continuous improvement and GDP/GMP adherence.
Preferred
- Experience with robotics/motion-control or surgical device assembly with advanced troubleshooting.
- Working knowledge of process validation activities (IQ/OQ/PQ) and fixture validation.
- Exposure to continuous improvement methodologies.
Work Schedule
- Monday–Friday, 6:00 AM–2:30 PM (onsite); occasional evenings/weekends and overtime based on demand.
Required Skills (from posting)
- Accountability, Assembly Operations, Execution Focus, Good Manufacturing Practices (GMP), Process/Manufacturing Processes, Mechanical Equipments, Plant Operations, Organizing, Repair Management, Technologically Savvy.
Key Responsibilities
- Perform advanced electro-mechanical assembly and system-level integration of robotic modules (joints, control modules, sensors, cable harnesses) using work instructions and engineering documentation.
- Meet daily build targets in a structured production environment while complying with ISO 13485, FDA QSR, and GDP.
- Interpret and apply assembly procedures, MPIs, TPIs, and engineering documents to build, verify, and validate components across multiple product modules.
- Conduct functional, electrical, mechanical, and diagnostic testing using calibrated equipment and test procedures.
- Troubleshoot, diagnose, and rework complex electrical/mechanical issues; escalate systemic issues to engineering.
- Maintain compliance with ESD protection, clean manufacturing protocols, and contamination control standards.
- Document production, inspection, rework, and testing results in MES, ERP/SAP, and electronic DHR systems per GDP/GMP.
- Perform in-process inspections and support quality verifications.
- Participate in quality improvement initiatives (including investigations and CAPA support).
- Collaborate with Manufacturing leadership, NPI engineering, Quality, and Operations to support pilot builds and introductions.
- Provide feedback to engineering to improve MWI/MPI/TPI.
- Support training and on-the-job guidance for Technician I/II.
- Maintain certification and multi-module proficiency across at least five major robotic system modules.
- Prepare production lines (line clearance; verify equipment maintenance/calibration).
- Maintain material transaction accuracy and perform cycle counts for inventory.
- Report material shortages/discrepancies to prevent build interruptions.
- Identify workflow bottlenecks and support process efficiency improvements.
Qualifications
Education
- Vocational certificate, technical, or associate degree (or equivalent) required.
Required
- 4–5 years in medical device or electromechanical capital equipment manufacturing, with demonstrated GDP use in a regulated environment.
- Strong mechanical aptitude; ability to troubleshoot and support root cause investigations.
- Electrical troubleshooting proficiency (e.g., multimeters, grounding/isolation, diagnostic evaluation).
- Ability to complete multiple assembly/testing tasks while meeting workmanship, safety, and productivity expectations.
- Knowledge of ESD principles and hands-on ESD controls.
- Proficiency with precision assembly tools (torque wrenches, screwdrivers, calipers, tweezers, multimeters, presses, IPA, adhesives such as Loctite).
- Familiarity with ISO 13485, FDA QSR, and clean manufacturing practices.
- Effective communication/collaboration across manufacturing, engineering, quality, and operations.
- Ability to work independently in a fast-paced environment.
- Flexibility for overtime, early shifts, and weekends.
- Initiative and commitment to continuous improvement and GDP/GMP adherence.
Preferred
- Experience with robotics/motion-control or surgical device assembly with advanced troubleshooting.
- Working knowledge of process validation activities (IQ/OQ/PQ) and fixture validation.
- Exposure to continuous improvement methodologies.
Work Schedule
- Monday–Friday, 6:00 AM–2:30 PM (onsite); occasional evenings/weekends and overtime based on demand.
Required Skills (from posting)
- Accountability, Assembly Operations, Execution Focus, Good Manufacturing Practices (GMP), Process/Manufacturing Processes, Mechanical Equipments, Plant Operations, Organizing, Repair Management, Technologically Savvy.