Job Summary

The Mfg. Technician/Sr. Mfg. Technician works within the Manufacturing Engineering Department on Medical Class III and external products (active implantable devices). The Mfg. Technician/Sr. Mfg. Technician supports process characterizations & DOE’s, selects, and sets 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…). The Mfg. Technician/Sr. Mfg. Technician will be responsible for the installation of new controlled equipment and maintaining existing controlled equipment, as well as executing calibration of equipment as needed for releasing of equipment, tooling, or fixtures. The Mfg. Technician/Sr. Mfg. Technician is responsible for performing and maintaining preventive maintenance for controlled equipment. The Mfg. Technician/Sr. Mfg. Technician will work 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 South San Francisco.

Essential Duties and Responsibilities

• Calibration & Preventative Maintenance
  • Performs scheduled Preventive Maintenance and Calibration activities on-time from detailed written procedures on equipment.
  • Assist in the installation, set-up, testing, and qualification of new equipment, tools, or fixtures.
  • Assist in development and perform equipment validation testing.
  • Interacts with external Engineering Labs and Calibration suppliers to perform necessary calibration work for Presidio controlled equipment.
  • Maintains clear and concise records to comply with internal procedures and external regulations.
  • Perform data entry and documentation of work performed.
• Production & Engineering Assembly
  
  • Supports production and engineering builds as required.
  • Completes all Production documentation required for production and special request builds.
  • Assist in Design Verification/Validation testing as required.
  • Assist in process verification/validations testing as required.
  • 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.
  • Create and release DCO’s per the internal Presidio Medical process.
  • Support the Quality System and Quality Policy by following procedures / work instructions and creating records to meet the requirements of the Quality System.

Qualification Requirements
Experience/Education:

• Minimum 2 years Technical Degree or Trade School or equivalent industrial experience.
• 1-3 years related experience in a medical device manufacturing environment preferred.

Personal 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.

 Social Competencies:

• Proven ability to work in an ambiguous environment and collaborate across multiple areas in order to achieve a common business objective.

Professional Competencies:

• Experience with process validations (IQ-OQ-PQ), Lean Sigma and 6S is a plus.
• Experience drafting required technical documents that are clear and easy to follow.
• Detail oriented.
• Well organized and motivated.
• Experience in calibration and preventative maintenance processes.
• Basic skills in software applications, such as Microsoft Office and Solidworks, is a plus.
• Experience in Jig & Fixture design a plus.

Physical Demand

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