MFG Technician XOFT- San Jose, CA jobs in United States
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Elekta · 1 month ago

MFG Technician XOFT- San Jose, CA

Elekta is a leader in precision radiation therapy committed to improving cancer care. They are seeking a Manufacturing Technician (Xoft) to perform medical device assembly and processing tasks as part of the production team, ensuring adherence to quality management and safety standards.

BiotechnologyHealth Care
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H1B Sponsor Likelynote

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

Qualification

Medical device assemblyMeasurement equipment proficiencyFDA 510k knowledgeISO 13485 knowledgeGMP familiarityBasic computer skillsFluent in EnglishEffective communicationInitiativeContinuous learning

Required

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)
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
Work may occur in a Cleanroom, following Gowning Protocols

Preferred

Familiarity with GMP (Good Manufacturing Practices) is advantageous

Benefits

Excellent Medical, Dental and Vision coverage
401k, paid vacation and holiday
A wealth of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending account
Close-knit company culture
Career development – wide range of learning opportunities

Company

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders.

H1B Sponsorship

Elekta has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (8)
2023 (1)
2022 (8)
2021 (11)
2020 (17)

Funding

Current Stage
Public Company
Total Funding
unknown
2002-06-28IPO

Leadership Team

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Jakob Just-Bomholt
President and Chief Executive Officer
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Anming Gong
Executive Vice President
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Company data provided by crunchbase