Engineering Technician

Planet Pharma; Los Gatos (CA); On-site; USD 55,000 - 75,000; Part time

Job summary

Planet Pharma is seeking a dedicated assembler/tester for a 6-month contract in Los Gatos, CA. The role involves assembling and testing medical devices under tight tolerances, following GMP and FDA regulations, and maintaining precise documentation.

Ideal candidates have 4–7 years in medical device manufacturing, experience with microscopes, and the ability to train others. Overtime may be required, with potential for extension or conversion to a longer-term position.

Qualifications

• High School graduate equivalent required.
• AA in a technical field preferred.
• Minimum 4-7 years related experience in the medical device industry.
• Ability to read and interpret engineering drawings, schematics, and assembly instructions.
• Ability to perform precision work requiring sustained use of a microscope.

Responsibilities

• Assemble medical devices under microscope using complex assembly processes per documented procedures.
• Assist in training new hires on manufacturing procedures and techniques.
• Test medical devices using documented test methods.
• Inspect components, sub-assemblies, and final assemblies as needed.
• Support continuous improvement initiatives, including process optimization and defect reduction, by providing feedback to the Operations team on manufacturing process effectiveness.
• Verify that the maintenance and calibration of manufacturing equipment and tooling are current and compliant with documented procedures.
• Maintain accurate records/documentation related to quality, work in progress, test results, labor, and special projects.
• Review completed Manufacturing document to ensure accuracy and compliance with Good Documentation Practices
• Communicate work status, issues, or concerns to the supervisor in a timely manner.

Job description

6-month contract, potential for extension or conversion

Purpose of the job:

Assemble and test medical devices while following documented procedures, quality standards, GMP, and FDA regulations. Support production operations through accurate documentation, equipment compliance, teamwork, training, and continuous improvement efforts.

MAJOR DUTIES AND RESPONSIBILITIES

• Assemble medical devices under microscope using complex assembly processes per documented procedures.
• Assist in training new hires on manufacturing procedures and techniques.
• Test medical devices using documented test methods.
• Inspect components, sub-assemblies, and final assemblies as needed.
• Support continuous improvement initiatives, including process optimization and defect reduction, by providing feedback to the Operations team on manufacturing process effectiveness.
• Verify that the maintenance and calibration of manufacturing equipment and tooling are current and compliant with documented procedures.
• Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g., timecards), and special projects.
• Review completed Manufacturing document to ensure accuracy and compliance with Good Documentation Practices
• Communicate work status, issues, or concerns to the supervisor in a timely manner.
• Maintain a clean, organized, and compliant work environment, including cleanroom operations as needed.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations.
• Work all required overtime as needed.
• Perform other duties as assigned.

Preferred QUALIFICATIONS

Education and/or Job Experience

• High School graduate equivalent required.
• AA in a technical field is preferred.
• Minimum 4-7 years related experience in the medical device industry.
• Ability to read and interpret engineering drawings, schematics, and assembly instructions.
• Ability to perform precision work requiring sustained use of a microscope for extended periods.

Skills, Abilities, and Requirements

• Experience with fabrication, equipment, or tight tolerance assembly.
• Experience using hand tools, microscopes, measuring devices, and precision equipment.
• Proven attention to detail and documentation accuracy.