Operator I

Job Title - Operator I

Location - Pleasanton, CA

Shift: 5:00 AM 1:30 PM

Duration - 6 months

Job Summary:

Responsible for producing high-quality medical devices in a manufacturing cell. Work is performed under close supervision and may include assembly, repair, and testing of pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Routine assignments are performed according to standardized procedures, with continuous review.

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Key Responsibilities:

• Perform assembly, repair, and testing of medical devices.


• Follow written procedures and verbal instructions accurately.


• Ensure all job documentation is complete, accurate, and up-to-date.


• Communicate clearly ideas, problems, and solutions to all levels of management.


• Maintain a positive attitude with internal and external customers (including tours).


• Follow all safety guidelines and use appropriate safety devices.


• Participate in continuous improvement and quality initiatives to enhance production processes.


• Maintain accurate records for traveler and quality documents; ensure all parts are traceable.


• Support Lean Manufacturing principles.


• Work with Manufacturing Supervisor/Manager to set and monitor individual goals and cell performance metrics.


• Support divisional initiatives in line with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.


• Utilize electronic data collection systems and computer software packages.


• Prioritize work based on job sequencing and importance.


• Handle and maneuver small components and parts.


• Make critical decisions with minimal supervision.

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Skills & Experience Desired:

• Soldering experience (desired).


• 6 months to 2 years of relevant experience.


• Experience using microscopes, tweezers, EFD epoxy dispensers, and calipers (desired).


• Basic GMP familiarity (desired).


• Knowledge of IPC, Good Documentation Practices.


• Detail-oriented due to complex products.

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Qualifications:

• High school degree or equivalent required.

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Dress Code & Personal Appearance Rules:

• Clothing must be non-shedding and free of frayed hems, loose threads, tassels, fringes, glitter, sequins, or anything that could come off.


• Fabric must pass a pull test; no loose fibers allowed.


• Sweaters, sweater vests, loose fiber garments, loose knit, or fleece are not allowed.


• Clothing must fit under lab coat/gown; turtlenecks/high-necked clothing must stay under lab coat.


• Sleeves must not extend beyond lab coat cuffs.


• Headwear (caps, hats, scarves, bandanas) not allowed under bouffant; religious scarves must be fully covered.


• Shoes must be worn at all times; no sandals, clogs, slippers, open toes/heels; heels ? 2 inches; toes not exposed.


• Pants, skirts, and tops must fully cover torso, upper arms, and legs.


• Nail polish, acrylics, artificial nails, or coatings not allowed.


• Jewelry or body piercings must be covered under gown.


• Makeup is not allowed; lip balm in stick form only, applied outside production areas.


• Scented personal products not allowed; lotions not applied after hand washing.


• Open or bleeding wounds must be covered.


• Avoid anything offensive or unsafe in production areas.

Keywords: assembler, operator, assembly, medical device , soldering



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