Manufacturing Operator

Job Summary

The Manufacturing Operator (MO) works within the Manufacturing Engineering Department on Medical Class III and external products (active implantable devices). The Manufacturing Operator’s job is to execute the production process, ensuring that products are made safely, efficiently, and to the required quality standards. The Manufacturing Operator will also support setting up equipment for pilot lines, supports initial manufacturing builds, sets up, executes, and documents engineering tests, works on manufacturing process improvements and establishes manufacturing documentation (BOM, assembly procedures, travelers, work instructions…). He/She works in a cross-functional team with R&D, manufacturing, purchasing, planning and quality to develop the manufacturing of new products. This position will be based on site in San Mateo.

Essential Duties and Responsibilities

• Executing Production and Engineering builds
• Setting up and maintaining equipment
  • Manufacturing operators may install tools, read blueprints/engineering drawings, and set up equipment.  
•  Operating machinery
  • They may feed raw materials into machines, operate machines, and perform minor repairs.
•  Monitoring production
  • Manufacturing operators may monitor product standards, production equipment, and the overall efficiency of the production process.
•  Enforcing safety protocols
  • Manufacturing operators are responsible for following safety procedures to protect themselves and their colleagues.
•  Performing quality control checks
  • Manufacturing operators may inspect parts, test finished materials, and document any defects or issues.
•  Labeling and tagging products
  • Manufacturing operators may label and tag products to encourage customers to make a purchase.
•  Communicating
  • Manufacturing operators may interact with others, inform colleagues about safety procedures, and prepare detailed reports.
• Continuous Improvements
  • Manufacturing operators may troubleshoot and identify areas of improvement in the manufacturing process.
  • Create or modify process work instructions as required.
•  General
  • Support R&D, Mfg. Eng., Facilities, Operations and Quality as required.

Qualification Requirements

Experience/Education:

• Minimum 2-5 years in manufacturing/production operator experience.
• 1-3 years related experience in a medical device manufacturing environment preferred.
• Minimum of a High school diploma or GED equivalent.

Competencies:

• Proven ability to work creatively and analytically in a problem-solving environment, demonstrating teamwork, innovation and excellence.
• Self-motivated, decisive, with the ability to adapt to change and competing demands.
• Flexible with proven ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
• Proven ability to work in an ambiguous environment and collaborate across multiple areas in order to achieve a common business objective.
• Detail oriented to create robust documentation.
• Basic skills in software applications, such as Microsoft Office
• Computer skills to be able to update/upload software onto a device with given work instructions
• Well organized and motivated to deploy robust processes.
• Experience in drafting comprehensive and well written Assembly Procedures, Travelers, Work Instructions, and other technical documents that are clear and easy to follow. 
• Experience with process validations (IQ-OQ-PQ), Lean Sigma and 6S is a plus.

Physical Demand

• Varied sitting, standing, and walking.
• Ability to lift and carry 50lbs. or less.