Sr. Assembler

Gener8•San Jose, CA

5d•Onsite

About The Position

The Sr. Assembler provides advanced technical support to manufacturing operations by performing complex assembly, testing, calibration, and integration of manufactured products and subassemblies. The role serves as a floor technical lead for production builds, issue resolution, and continuous improvement. Work must follow Good Documentation Practices (GDP), approved procedures, drawings, and specifications to ensure products meet safety, performance, and regulatory requirements in alignment with ISO 13485 and FDA 21 CFR 820. The position is on-site in San Jose, California, and is intended for local applicants within the area of employment. It requires gowning procedures for a controlled environment and working around high-speed machinery, hydraulics, electrical and pneumatic systems. Lockout/tagout procedures and appropriate personal protective equipment must be used as required.

Requirements

High school diploma or equivalent.
Four to seven years of experience in manufacturing, assembly, or test roles; regulated-industry experience is preferred.
Demonstrated experience with system-level testing and calibration and advanced troubleshooting.
Ability to read and interpret drawings, specifications, work instructions, and test procedures.
Strong hands-on experience with assembly, integration, testing, and calibration using calibrated tools and equipment.
Proven troubleshooting and problem-solving skills, including structured failure isolation and clear documentation.
Working knowledge of regulated manufacturing expectations, including ISO 13485, FDA 21 CFR 820, and Good Documentation Practices.
Familiarity with traceability, serialization and labeling, and manufacturing recordkeeping such as DHRs and travelers.
Strong communication, teamwork, and mentoring skills, with the ability to coordinate effectively with Engineering and Quality.
Ability to follow gowning procedures and applicable safety requirements, including lockout/tagout and use of required PPE.

Nice To Haves

Technical certification, vocational training, or an associate degree.
Experience supporting NPI builds, process changes, or production ramp activities.
Familiarity with ESD controls and basic metrology.
For electronics builds, familiarity with applicable IPC workmanship standards such as IPC-A-610.

Responsibilities

Build, integrate, and test complex mechanical and electromechanical subassemblies and systems according to controlled documentation.
Perform system-level functional testing, calibration, and verification using approved methods and calibrated equipment.
Execute and document setup, changeover, and verification activities to maintain consistent and repeatable manufacturing processes.
Support pilot builds and transfers from engineering to production, providing manufacturing feedback to improve design for manufacturability and assemblability.
Troubleshoot and isolate failures; coordinate with Engineering and Quality on disposition, rework, or repair.
Support daily manufacturing schedules, identify risks to schedule, yield, or quality, and escalate issues appropriately.
Provide technical guidance, mentoring, and on-the-job training to technicians and assemblers using approved work instructions.
Participate in daily stand-ups and communicate production status, blockers, and containment actions.
Coordinate with Engineering, Quality, and Supply Chain to resolve material, process, and test issues.
Support NCR/MRB activities by providing technical input, performing authorized rework or repair, and documenting results.
Complete manufacturing records, including travelers, build/test logs, and calibration records, accurately, legibly, and in real time.
Maintain traceability, including part, lot, and serial tracking and labeling or serialization steps as applicable.
Verify that tools and equipment are calibrated and report out-of-tolerance conditions or equipment issues according to procedure.
Identify, document, and escalate nonconforming conditions; support containment and corrective actions as assigned.
Maintain ESD, cleanliness, safety, and 5S expectations and keep the work area organized, controlled, and audit-ready.