What are the responsibilities and job description for the Sr. Technician, Manufacturing position at Gener8, LLC?
Job Title: | Sr. Technician, Manufacturing |
Reporting to: | Manufacturing Manager |
Location: | San Jose, CA |
Job Site: | On-Site |
Job Description Revision Date: | February 20, 2026 |
About us:
Gener8 is an innovative tech company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica. We know what it takes to be a key partner in the life science and medical device industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering and software design services and manufacturing complex instruments and consumables. Our customers are striving for breakthroughs in medical research and diagnostic applications as well as surgical devices that help scientists and medical professionals understand and diagnose diseases and improve patient treatment outcomes.
Purpose
Provides advanced technical support to manufacturing operations through complex assembly, testing, calibration, and integration of manufactured products and subassemblies. Serves as a floor technical lead to support production builds, issue resolution, and continuous improvement. Performs work in accordance with 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.
SPECIFIC DUTIES AND RESPONSIBILITIES
- Manufacturing & Test Activities:
- Build, integrate, and test complex mechanical and electromechanical subassemblies and systems per controlled documentation.
- Perform system-level functional testing, calibration, and verification using approved test methods and calibrated equipment.
- Execute and document setup, changeover, and verification activities to ensure consistent and repeatable manufacturing processes.
- Support pilot builds and process transfers from engineering to production; provide manufacturing feedback to improve DFx/assemblability.
- Perform advanced troubleshooting and failure isolation; coordinate with Engineering and Quality for disposition, rework, or repair as required.
- Production Support & Coordination:
- Support daily manufacturing schedules with minimal supervision; identify risks to schedule, yield, or quality and escalate appropriately.
- Provide hands-on technical guidance and mentoring to technicians and assemblers, including on-the-job training to approved work instructions.
- Participate in daily stand-ups and communicate status, blockers, and containment actions for issues impacting production.
- Coordinate cross-functionally with Engineering, Quality, and Supply Chain to resolve material, process, and test issues.
- Support NCR/MRB activities by providing technical input, performing rework/repair per approved instructions, and documenting results.
- Quality & Compliance:
- Follow GDP and complete manufacturing records (e.g., travelers, build/test logs, calibration records) accurately, legibly, and in real time.
- Ensure traceability requirements are met, including part/lot/serial tracking and labeling/serialization steps as applicable.
- Verify use of calibrated tools and equipment; report out-of-tolerance conditions or equipment issues per procedure.
- Identify, document, and escalate nonconforming conditions; support containment and corrective actions as assigned.
- Maintain ESD, cleanliness, safety, and 5S expectations; keep work area organized, controlled, and audit-ready.
Supervisory responsibilities
- No direct supervisory responsibilities. Provides technical leadership, mentoring, and training support.
Education
- High school diploma or equivalent required.
- Technical certification, vocational training, or associate degree preferred.
- Equivalent hands-on manufacturing experience fully acceptable.
Experience
- 4–7 years experience in manufacturing, assembly, or test roles (regulated industry preferred).
- Demonstrated experience with system-level testing/calibration and advanced troubleshooting.
- Experience supporting NPI builds, process changes, or production ramp activities preferred.
Knowledge, Skills and TraininG
- Ability to read and interpret drawings, specifications, work instructions, and test procedures.
- Strong hands-on experience with assembly, integration, test, and calibration activities 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 GDP.
- Familiarity with traceability, serialization/labeling, and manufacturing recordkeeping (DHR/travelers).
- Strong communication, teamwork, and mentoring skills; able to coordinate effectively with Engineering and Quality.
- Preferred: ESD controls; basic metrology; and for electronics builds, familiarity with IPC workmanship standards (e.g., IPC-A-610) as applicable.
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Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.
Salary : $29 - $48