Manufacturing ​/ Production Operator, Quality Engineering

Operator I - Assembly

Pleasanton, CA 94588

Duration: 6+ Months

Mon - Fri 5:00AM TO 1:30 PM

"This is a non‑exempt position. This position is responsible for the production of high‑quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical‑device assemblies. Performs routine assignments according to specified and/or standardized procedures. Work is closely and continually reviewed. Ensure that relevant job documentation for cell operations and functions is accurate and up to date.

Be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form. Maintain a positive attitude when interacting with internal customers and external customers such as tours. Follow safety guidelines and utilize appropriate safety devices when performing all operations. Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.

Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products. Demonstrates a basis understanding of Lean Manufacturing. Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.">

• Produce high‑quality medical devices within a manufacturing cell.
• Perform assembly, repair, and test operations on pacemakers, ICDs, leads, and related assemblies under close supervision.
• Execute routine assignments according to specified or standardized procedures.
• Work is closely and continually reviewed.
• Ensure job documentation for cell operations and functions is accurate and up to date.
• Communicate ideas, problems, and solutions to all levels of manufacturing management in written and oral form.
• Maintain a positive attitude when interacting with internal and external customers such as tours.
• Follow safety guidelines and utilize appropriate safety devices during all operations.
• Participate in continuous improvement/quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable, and quality issues are addressed.
• Demonstrate a basis understanding of Lean Manufacturing.
• Collaborate with the Manufacturing Supervisor/Manager to set and monitor individual goals and cell performance metrics that continuously seek to improve the quality of operations.
• Support all Divisional initiatives identified by divisional management and in support of QMS, EMS, and other regulatory requirements.

• Ability to read, comprehend, and follow written procedures.
• Understand and follow verbal instructions.
• Understand and utilize electronic data collection systems and computer software packages.
• Ability to prioritize work by determining sequencing and timing of different jobs based on precedence and importance.
• Ability to handle and maneuver small components and parts.
• Ability to make critical decisions and judgments with minimal supervision.
• High school degree or equivalent required.

Required dress code for tours during interview and on-the-job:
Clothing must be non‑shedding and free of frayed hems or loose threads. Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodged are not allowed on clothing. To verify a fabric can be worn: pull at the fabric tightly with fingers; if fibers are dislodged, the garment may not be worn in the production area.

Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn. All clothing must be clean and free of…