Job Title: Manufacturing Engineer Technician

Job Description

The Manufacturing Engineer Technician is tasked with providing essential engineering support for both production and product development. This role involves formulating manufacturing batches and solutions, preparing and updating technical reports, drawings, and specifications. Additionally, the technician supports the execution of IQ, OQ, and PQ validations, recurring validations of equipment, tooling, processes, and products, and collaborates with cross-functional teams to qualify medical devices.

Responsibilities

• Formulate manufacturing batches and solutions used during the manufacturing process.
• Prepare, update, and maintain technical reports, drawings, and specifications.
• Support the execution of IQ, OQ, PQ validations and perform recurring validations of equipment, tooling, processes, and products.
• Collaborate with cross-functional teams for the qualification of medical devices.
• Assist in selecting, developing, and improving processes, tooling, and equipment to reduce costs or enhance quality.
• Maintain and repair equipment as necessary.
• Conduct tests on prototypes or systems and troubleshoot production equipment and process problems.
• Support calibration, maintenance, and repair of production equipment.

Essential Skills

• Hands-on experience in manufacturing, formulation, validation, testing, and troubleshooting.
• Proficiency in equipment validation, process validation, and sterilization.
• Ability to write comprehensive technical reports.
• Experience in the medical device, pharmaceutical, aerospace, or cleanroom industries.
• Bachelor's Degree in Engineering, Chemical Engineering, Chemistry, or a related field.
• 1-2 years of experience in a regulated manufacturing environment.
• Experience with basic clean room laboratory technology.

Additional Skills & Qualifications

• Experience in medical device, pharmaceutical, or other regulated industries.
• Experience supporting the execution of validation protocols.
• Knowledge of ISO 9001 standards.

Work Environment

The position is 100% onsite with a start time of 6 or 7 AM, based out of the production site. The team includes a VP of R&D, Director of R&D, Engineering Manager, Engineering Manager, and Engineering Technician. The production site primarily houses manufacturing, engineering, and clean room production with about 40 people onsite. The organization fosters a collaborative work environment with opportunities for professional growth and development, particularly in validation, process improvement, and technical support.

Job Type & Location

This is a Contract to Hire position based out of Glendora, California.