MFG Technician XOFT- San Jose, CA

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This is an on-site job at the San Jose, CA office 5 days a week

 

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 work space

·         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 to 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 ma...