Description
This position performs a variety of complex medical assembly and processing tasks as a Product Builder 3 and function as a skilled member of the production team. The Product Builder III will directly be involved in a production line and support Production Coordinator, Line Leads, Trainers, and Production Supervisor to achieve necessary goals. With a clear understanding of a Product Builder I and II role and responsibilities, this role will support the production floor and build product to meet the production schedule supporting the customer demand. Operate tools & equipment, inspect in-process components and complete documentation as required. All employees shall always perform their activities with Safety, Quality, Integrity and informing the Lead and Supervisor of any nonconforming product.
Responsibilities
- Follow and adhere to Standard Operating Procedures, Work Instructions, assembly methods, product handling methods, Good Documentation Practices, current Good Manufacturing Practices, and Safety requirements
- Responsible for producing quality products– Act as Quality control when examining output to ensure 100% adherence to requirements and in-process unit inspection throughout the build processes. Inspection includes product, documentation, handling and control.
- Perform single or limited number of core task to support continuous improvement initiatives and project.
- Responsible for manufacturing part families and/or operations on all builds that include but are not limited to multi-lumen, and steerable catheters.
- Understand travelers, how to identify materials, use a microscope and use production/inspection tools and equipment needed for product builds. Apply proper identification of materials and product as needed.
- Be able to clearly explain problems and give instructions to others involved keeping operations running.
- Be able to assist in training when needed.
- Perform line clearance activities.
- Assist in tracking and monitoring production performance.
- Maintain a clean general work area during the shift and proper cleaning at the end of each shift.
- Take initiative to find work when necessary.
- Complete forms as defined by industry standards.
- Additional duties as assigned.
Qualifications
Required Qualifications:
- High School diploma or GED or equivalent experience
- Minimum 3 years of medical device assembly experience in a cleanroom
- Minimum 2 years experience with assembly and inspection using a microscope
- Willing to work in a team environment and promote teamwork among others
- Demonstrate a clear understanding of all shop floor paperwork and basic blueprints/specifications
- Basic math abilities
- Ability to perform the job with no supervision
- Attention to detail and instructions
- Proficient in the use and set-up of all production tools and equipment for building and inspecting product
- Basic skills of reading, writing, and speaking English
Preferred Qualifications:
- Basic computer skills: Excel, Word
- Working knowledge of ISO 13485 and cGMP
