Medical Device Technician

Position Overview:

The Medical Device Technician will be responsible for the assembly, inspection, packaging, and sterilization of medical devices in accordance with strict quality standards and regulatory requirements. This role requires attention to detail, strong organizational skills, and the ability to work efficiently in a fast-paced, team-oriented environment. The ideal candidate will adhere to Good Manufacturing Practices (GMP), perform regular maintenance on equipment, and participate in continuous improvement activities to ensure optimal product quality and production efficiency.

Essential Duties and Responsibilities:

• Cross-functional Collaboration: Develop and maintain strong internal working relationships across all departments, with a focus on achieving departmental and organizational goals.
• Work Planning and Adaptability: Prioritize, plan, and adapt work activities to meet production deadlines and objectives while adjusting to changing conditions.
• Machine and Equipment Maintenance: Execute daily start-up and maintenance activities for production equipment; perform machine set-ups as required.
• Inspection and Assembly: Inspect components and assemblies for quality and compliance with specifications; perform necessary assembly and packaging tasks.
• Sterilization and Labeling: Perform cleaning, pouching/sealing, labeling, and sterilization operations for medical devices.
• Documentation: Strict adherence to Good Documentation Practices (GDP) when completing assignments, ensuring all required records are accurate and up to date.
• ERP System Transactions: Perform timely and accurate transactions within the ERP system to track and manage production workflows.
• Inventory Control: Participate in inventory cycle counts, variance investigations, and reconciliation processes to ensure accurate stock levels.
• Process Improvement: Assist in conducting process capability studies, equipment installation qualifications, and process validation activities. Contribute to the investigation and implementation of corrective actions for product or process failures.
• Compliance: Adhere to all company policies, procedures, and safety regulations, including use of personal protective equipment (PPE), Standard Operating Procedures (SOPs), Work Instructions (WI), and Good Manufacturing Practices (GMP).
• Vendor Relations: Collaborate with vendors to address equipment repair or refurbishment needs.
• Workplace Maintenance: Ensure manufacturing areas are well-maintained, clean, and safe, adhering to established cleanliness and safety standards.
• Feedback and Continuous Improvement: Review and provide feedback on manufacturing documentation, assembly procedures, inspection protocols, test methods, and packaging processes.
• Other Duties as Assigned: Perform any other tasks or projects as assigned by management to support departmental and company objectives.

Qualifications:

• High school diploma or equivalent; technical education preferred.
• Minimum 2 years of work experience in a medical device or regulated manufacturing environment.
• Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office applications.
• Knowledge of ISO standards, Good Manufacturing Practices (GMP), and regulatory requirements for medical devices.
• Excellent written and verbal communication skills, with demonstrated ability to read, interpret, and follow comprehensive work instructions and guidance documents.
• Shipping, receiving, or stockroom experience is a plus.
• Ability to adapt to changing work environments and priorities.

Skills and Abilities:

• Attention to Detail: Ability to work with precision and maintain high-quality standards in a fast-paced environment.
• Communication Skills: Strong verbal and written communication skills to interact with team members, supervisors, and vendors.
• Self-Motivated and Team-Oriented: Ability to work independently with minimal supervision and as part of a collaborative team.
• Problem-Solving and Organizational Skills: Ability to identify and solve problems, prioritize tasks, and manage time effectively.
• Manual Dexterity: Comfortable working with tools, inspection gauges, and equipment of various sizes.
• Flexibility: Ability to work overtime, extended hours, or weekends as needed to meet business demands.
• Multitasking: Ability to juggle multiple tasks and responsibilities simultaneously while maintaining accuracy.

Physical and Working Conditions:

• Physical Requirements: Ability to lift, push, and pull up to 40 lbs. and stand for extended periods.
• Cleanroom Environment: Ability to work in a Class 10,000 or ISO Class VII cleanroom environment for prolonged periods.
• Personal Safety Equipment: Ability to work in areas requiring safety equipment, including eye protection and dust masks.
• Environmental Conditions: Ability to work in an environment with fluctuating temperatures, noise, and odors. Must be aware of potential hazards and adhere to safety standards

FLS

Job Type: Contract

Pay: $20.00 - $23.00 per hour

Application Question(s):

• Do you prefer 1st or 2nd shift?

Education:

• High school or equivalent (Required)

Experience:

• Cleanroom: 1 year (Required)

Shift availability:

• Night Shift (Required)
• Day Shift (Required)

Work Location: In person

Salary : $20 - $23