MFG Technician XOFT- San Jose, CA

MFG Technician XOFT- San Jose, CA Supply Chain & Manufacturing Posted 20 Days Ago San Jose, United States of America We don’t just build technology. We build hope for everyone dealing with cancer. This is an on-site job at the San Jose, CA office 5 days a week 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. 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 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: Recognizing opportunities and taking proactive steps. Competencies: · 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 What you’ll get: In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits. What we offer: 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 How to proceed? We are looking forward to hearing from you! Apply by submitting your application and résumé in English, via the “Apply” button. Please note that we do not accept applications by e-mail. We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic. The US base salary range for this position is $32-35/hr. About Elekta As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders. More than 6,000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable, outcome-driven, and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with presence in more than 120 countries and listed on Nasdaq Stockholm. For more information, visit elekta.com or follow @Elekta on Twitter and on LinkedIn.