MFG TECHNICIAN - PRODUCTION- San Jose, CA

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The Manufacturing Technician (Xoft) performs a range of medical device assembly and processing tasks as part of the production team.
Responsibilities:
• Assemble, inspect, test, package, and label medical devices per documented procedures.
• Complete production documentation accurately and follow quality management and safety standards.
• Execute tasks based on production orders, drawings, and work instructions, consulting the manager on progress and priorities.
• Perform final testing, record data in measurement reports, and assign lot/serial numbers to products.
• Participate in the manufacturing team’s processes and contribute to facility safety as a
member of the Xoft safety team.
• Transact Manufacturing Orders using the ERP system.
• Manage inventory accurately, in assigned workspace
• Participate in Inventory Counting in preparation for Audits
• Represent process steps where trained, during Quality System Audits.
• Document accurate work instructions for all processes and collaborate with the manager to design and produce assembly tools.
• Support other production teams as needed.
• Adhere medical regulations regarding Medical Device Manufacturing (FDA 510, ISO 13485, MDR).
• Follow Lean Manufacturing principles, including waste reduction and 5S practices.
• Take initiative in proposing and implementing improvements, actively contributing to projects.
• Technical background equivalent to Grade 12.
Qualifications:
• Experience and/or a desire to learn high-skill medical device cable assembly.
• Ability to assemble micro-scale devices under a microscope for extended periods.
• Proficiency in using measurement equipment and maintaining accurate process records.
• Knowledge or experience in medical product treatment standards (e.g., FDA 510k, ISO 13485 guidelines).
• Familiarity with GMP (Good Manufacturing Practices) is advantageous.
• Resourceful in ordering parts, working with vendors, and daily problem-solving.
• Ability to maintain detailed records following good documentation practices
Skills:
• Basic computer knowledge and skills.
• Fluent in English (written and oral).
• A continuous desire to learn new processes and skills.
• Effective communication skills: sharing information, knowledge, openly and honestly.

Actively listening and clarifying messages.

Demonstrating consistency between words and actions.
• Initiative: Recogni...