MFG Technician AND Equipment Xoft

High school diploma, GED, or equivalent.
Technical background equivalent to Grade 12
Fluent in English (written and oral)
Basic computer knowledge and skills
Ability to assemble micro-scale devices under a microscope for extended periods
Proficiency in using measurement equipment and maintaining accurate process records
Experience with equipment maintenance and following preventative maintenance procedures
A continuous desire to learn new processes and skills
Effective communication skills: sharing information, knowledge, and experience openly and honestly
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

Process X-ray sources through high vacuum systems (E&S – Exhaust & Seasoning)
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
Manage equipment maintenance, repair, and calibration; coordinate facility servicing with vendors and contractors
Participate in the manufacturing team’s processes and contribute to facility safety as a member of the Xoft safety team
Ensure the quality of test tools, measuring instruments, and other equipment
Propose adjustments to drawings, recipes, processing times, and related items to the manager
Document accurate work instructions for all processes and collaborate with the manager to design and produce assembly tools
Provide support to other production teams as needed
Assist in training and guiding new or less experienced employees
Adhere to medical regulations for handling equipment (FDA 510, ISO 13485, MDD)
Follow Lean Manufacturing principles, including waste reduction and 5S practices
Take initiative in proposing and implementing improvements, actively contributing to projects
Identify and act on continuous improvement opportunities in daily tasks

Preferred experience in high technology or medical device manufacturing
Two years of production assembly and/or testing experience preferred
Higher education or trade school training preferred
Knowledge or experience in medical product treatment standards (e.g., FDA 510k, ISO 13485 guidelines)
Familiarity with GMP (Good Manufacturing Practices) is advantageous
Knowledgeable in maintaining, operating, and troubleshooting equipment, particularly ovens and gas systems
Responsible for monthly, quarterly, and annual preventative maintenance on equipment, including clean room flow hoods, high-temperature furnaces, equipment temperature controllers, and calibrations
Resourceful in ordering parts, working with vendors, and daily problem-solving
Ability to maintain detailed records following good documentation practices