MFG Technician XOFT- San Jose, CA

Elekta•San Jose, CA

1d•Onsite

About The Position

The Manufacturing Technician (Xoft) is an individual contributor responsible for the hands-on assembly, testing, inspection, and packaging of medical devices in accordance with documented manufacturing procedures and regulatory requirements. This role executes production activities independently, following production orders, drawings, work instructions and manufacturing procedures while maintaining high standards of quality, safety, and compliance. The technician accurately completes production and quality documentation, performs final testing and measurement reporting, assigns lot and serial numbers, and transacts manufacturing orders in the ERP system. This role also maintains accurate inventory within the assigned workspace, participates in inventory counts and audit preparation, and represents trained process steps during quality system audits. As an individual contributor, the Manufacturing Technician collaborates closely with the manufacturing team and manager, contributes to facility safety initiatives (including participation on the safety team), supports other production members as needed. The role actively applies Lean Manufacturing principles, including waste reduction and 5S, and takes initiative in proposing and implementing process improvements.

Requirements

Technical background equivalent to Grade 12.
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.
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: Recognizing opportunities and taking proactive steps.
Commitment and involvement: proactive, results-oriented, enthusiastic, self-driven.
Committed to quality: efficient, sets high standards, focused on improvement.
Adaptability to changes: flexible and open to new ideas.
Demonstrates creativity: innovative and visionary thinking.
Positive influence: confident, assertive, and persuasive, creating a positive impression.
Takes responsibility for personal development: self-aware, motivated, and curious.
Expert knowledge: skilled, professional, up-to-date.
Effective teamwork: supportive, encouraging, cooperative

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.