Job Summary:The Manufacturing Technician position is responsible for the manufacture, inspection, and final product packaging and sterilization of Conformis implants and components.2nd Shift - Mon - Fri, 3:00pm - 11:30pmEssential Duties and Responsibilities:
- Develop and maintain strong internal working relationships across Conformis.
- 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.).
Conformis is an Equal Opportunity Employer