Manufacturing Technician

Avance Consulting; Milpitas (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Avance Consulting is seeking a detail-oriented Manufacturing Technician to support our medical device manufacturing and engineering teams in Milpitas, CA. This role offers hands-on experience with innovative robotic systems and long-term career development.

You will perform advanced electro-mechanical assembly, lead testing activities, ensure ISO 13485, FDA QSR, GDP, and GMP compliance, document results, and collaborate with cross-functional teams to drive quality and throughput on multiple

Qualifications

• Experience with GDP in regulated environments.
• Proficient in basic electrical/mechanical test methods.
• Familiarity with ISO 13485, FDA QSR, GDP/GMP.
• Ability to interpret engineering docs and apply procedures.

Responsibilities

• Perform advanced electro‑mechanical assembly and system‑level integration of robotic modules.
• Lead complex assembly and testing activities with minimal supervision.
• Maintain ISO 13485, FDA QSR, GDP, GMP compliance in production.
• Document results in MES, ERP/SAP, and DHR systems.

Skills

Troubleshooting

Electromechanical assembly

Testing with multimeters

GDP knowledge

Regulatory compliance

ESD controls

ISO13485 knowledge

Team collaboration

Documentation

Overtime flexibility

Job description

We are seeking a detail-oriented and experienced individual who thrives in a fast-paced environment and is comfortable working independently while supporting manufacturing and engineering needs. This position offers hands‑on experience with innovative technology and opportunities for long-term career development.

Key Responsibilities

• Perform advanced electro‑mechanical assembly and system‑level integration of robotic system modules including joints, control modules, sensors, and cable harnesses using detailed work instructions, and engineering documentation.
• Lead complex assembly and testing activities across multiple robotic modules with minimal supervision.
• Operate within a structured production environment to meet build throughput and schedule commitments while maintaining compliance with ISO 13485, FDA QSR, GDP, and GMP requirements
• Interpret and apply assembly procedures, MPIs, TPIs, and engineering documents to correctly build, verify, and validate mechanical and electromechanical components across multiple product modules.
• Conduct functional, basic electrical, mechanical, and diagnostic testing using calibrated equipment, torque tools, multimeters, and approved software‑based test procedures.
• Troubleshoot, diagnose, and rework complex electrical and mechanical issues including alignment, sensor faults and calibration mismatches and escalates systemic issues to engineering.
• Maintain compliance with ESD controls, clean manufacturing practices, hazardous waste handling, and safety standards; promptly address safety concerns and support risk‑mitigation activities.
• Accurately document production activities, inspection results, rework actions, and test outcomes in MES, ERP/SAP, and electronic DHR systems following GDP and GMP standards.
• Perform in‑process inspections and contribute to quality verifications to ensure adherence to workmanship and regulatory standards.
• Actively participate in quality improvement initiatives by identifying issues, supporting engineering in investigations, corrective and preventive action implementation.
• Collaborate closely with Manufacturing leadership, NPI engineering, Quality, and Operations teams to resolve manufacturing challenges and support successful pilot builds and product introductions as well as identifying improvement opportunities.
• Support validation and calibration activities for assemblies, fixtures, and test systems as defined by engineering and quality requirements.
• Provide clear, actionable feedback to Engineering to improve MWIs/MPIs/TPIs and manufacturability.
• Support training, knowledge-sharing, and on‑the‑job guidance for Manufacturing Technician I and II team members, including assistance with complex assemblies and/or troubleshooting tasks.
• Maintain certification and demonstrate multi‑module proficiency across at least five major robotic system modules while upholding all safety, quality, and compliance requirements.
• Prepare production lines by performing line clearance, verifying equipment maintenance and calibration status, and ensuring material readiness—which includes accurate material transactions, cycle counts of raw materials, sub‑assemblies, and WIP, as well as proactively identifying and reporting shortages or discrepancies to prevent build interruptions and support efficient production scheduling.
• Contributes to process efficiency efforts by identifying workflow bottlenecks, recommending improvements, and supporting implementation of incremental process enhancements.

Qualifications

Required

• 3+ years of experience in medical device or electromechanical capital equipment manufacturing, with demonstrated use of Good Documentation Practices (GDP) in a regulated environment.
• Strong troubleshooting capability with familiarity in validation‑related activities.
• Solid electrical troubleshooting capability, including proficiency with multimeters, grounding/isolation techniques, and diagnostic evaluation of module failures.
• Ability to execute multiple assembly and testing tasks while consistently meeting workmanship, safety, and productivity expectations.
• Knowledge of ESD principles and hands‑on application of ESD controls in production environments.
• Proficiency with precision assembly tools such as torque wrenches, screwdrivers, hand drivers, calipers, multimeters, presses etc.
• Familiarity with ISO 13485, FDA QSR requirements, and clean manufacturing practices for medical device production.
• Effective communication and collaboration skills with the ability to work across manufacturing, engineering, quality, and operations teams.
• Ability to work independently in a fast‑paced environment while managing priorities and supporting production continuity.
• Flexibility to work overtime, early shifts, and weekends based on business needs.
• Demonstrated initiative with a commitment to continuous improvement and adherence to GDP/GMP expectations.

Work Schedule

• Occasional evening or weekend work may be required.
• Overtime may be required based on production demand.