Manufacturing Technician, 3rd Shift (Multiple Openings)

Job Summary:

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

3rd Shift – Sun – Thurs, 11:00pm – 7:30am

 

 

Essential Duties and Responsibilities:

  • Develop and maintain strong, internal working relationships across ConforMIS.
  • Understand the objectives, responsibilities, and mission of the Manufacturing department and works 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 and 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, 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, and 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.).

ConforMIS is an equal opportunity employer

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