Manufacturing Technician, 2nd Shift

Job Summary:

The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of restor3d implants and components.

2^nd Shift – Mon – Fri, 3:00pm – 11:30pm

Essential Duties and Responsibilities:

• Develop and maintain strong internal working relationships across restor3d.
• Understand the objectives, responsibilities, and mission of the Production department and work towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Execute daily maintenance and start-up activities.
• Perform machine set-ups.
• Perform inspection of components and assembly as required.
• Perform cleaning, pouching/sealing, labeling, and sterilization operations.
• Strict adherence to Good Documentation Practices when executing all assignments.
• Perform timely and accurate transactions of workflow in ERP system.
• Participate in inventory cycle counts, variance investigation, and reconciliation.
• Assist in performing required process capability studies, equipment installation qualifications, and process validation.
• Assist in the investigation and implementation of corrective actions on product and process failures.
• Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions, and Good Manufacturing Procedures.
• Interface with vendors to seek solutions for equipment repairs and refurbishment.
• Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
• Review all manufacturing documentation, assembly, inspection, test, and packaging procedures, and provide feedback.
• Other duties as assigned.

Qualifications:

• High School diploma or equivalent; Technical education preferred.
• 2 years’ work experience in a medical device and/or regulated environment.
• Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications.
• Familiar with ISO Standards and Good Manufacturing Practices.
• Excellent verbal and written communication.
• Demonstrated English reading and writing skills.
• Ability to understand and follow comprehensive work instructions and guidance documents.
• Shipping/receiving/stockroom experience a plus.

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Manual dexterity to handle tools, inspection gauges, and equipment of different sizes.
• Demonstrated organizational skills.
• Ability to work in a fast-paced environment and multitask. Comfortable with change.
• Flexible to work overtime, extended hours, and weekends as business demands.
• Ability to work as part of a team as well as independently.

Working conditions:

• Ability to lift, pull, and push up to 40 lbs.
• Ability to stand for prolonged periods of time.
• Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time.
• Capable of working in material blending area with necessary personal safety equipment (eye protection, dust masks).
• Busy work environment with frequent interruptions.
• Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies.
• Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust, etc.).

restor3d is an Equal Opportunity Employer