Job Summary:

This position provides leadership, direction and clear communication of the expectations and objectives on the NextPhase production floor. This position may require interacting effectively with various support groups such as Production Planning, Engineering, Product Development, Supply Chain, Quality, Customer Service, Materials and Human Resources. The position’s objective is to assist with properly allocating direct resources to achieve the planned goals in Safety, Quality, Delivery and Cost. The role of the Production Assistant includes the need to perform and ensure production assembly tasks are actively completed to meet production schedules while upholding the highest level of Quality. The Production Assistant will use a variety of hand and power tools, soldering irons, fixtures, work instructions and various other equipment to perform a series of operations to correctly assemble medical devices.

Responsibilities:

• Provide motivational leadership and direction to all associates to achieve Safety, Quality, Delivery, and Cost goals while enhancing teamwork.
• Communicate effectively with all internal contacts and support groups.
• Ensure proper training and adherence to Standard Operating Procedures (SOP’s) and applicable Quality Management System procedures in all operations and activities.
• Schedule operations in a manner that prevents delays and manpower is efficiently utilized.
• Assist with product floor challenges including but not limited to material shortages, tooling needs, etc.
• Assess and address training and cross training needs of associates to allow for maximum flexibility to support unexpected changes of customer demand.
• Perform various product assembly.
• Test various products for defects.
• Keeps records of departmental activities, as required.
• Assist with recommendations for hiring and releasing of production personnel as required maintaining production scheduling.
• Arranges to have appropriate production records prepared and maintained.
• Maintains adherence to company safety standards, policies, and clean room practices.
• Ensure proper Line Setup / Line Clearing / Product Traceability and that machinery and equipment are properly maintained.
• Maintain Kanbans, where applicable.
• Drive continuous improvement initiatives and tools.
• Recommend methods to simplify manufacturing processes to improve quality through repeatability, standardization and simple quality devices.
• Work with Engineering to investigate and resolve process issues and implementation of new products in the manufacturing area.
• Take on special projects as assigned.

Required Skills/Abilities:

• Excellent communication skills.
• Ability to prioritize work efficiently and effectively.
• Knowledge and ability to work in cleanroom environments.
• Commitment to company values.
• Basic math skills.
• Ability to read and interpret documents such as blueprints, work instructions and procedure manuals.
• Use of manual and electronic torque tools, and other wrenches and tools.

Preferred Skills/Abilities:

•  Ability to follow wire run diagrams for electro-mechanical system wiring.
•  Strong mechanical and electrical aptitude abilities.
•  Use of wire cutters, crimping tools, and soldering.
•  PCBA handling, integration, and connectively skills.
•  Proper ESD practices required.
•  Assembly of pneumatic and fluidic systems including pumps, tubing, and various interconnects.
•  Inspection tools such as vernier calipers and digital height gauges.
•  Mechanical and electrical troubleshooting of assemblies.
•  Use of microscopes for small assembly beneficial.
•  Use of part cleaning technologies such as ultrasonic cleaning.
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Education and Experience:

• 7+ years in a regulated manufacturing environment, experience in an ISO 13485:2016, FDA Quality System Regulation (21 CFR 820) compliant manufacturing environment is preferred.

• Understanding of Good Documentation Practices and Good Manufacturing Practices is required.

• Team leadership experience is required.

• Training experience is required.

• Cleanroom assembly experience, preferably ISO Class 7 is preferred.

• Experience with digital work order tracking software and working to time standards is preferred.

• High School graduate is preferred.

Physical Requirements:

•  Excellent hand-eye coordination and manual dexterity.
•  Must be able to stand for extended period of time (the duration of a shift).
•  Frequently stand, walk, and reach with arms.
•  Occasionally crouch or kneel and reach with arms.
•  Occasionally lift and/or move up to 50lbs.