Investigo · 10 hours ago
Manufacturing Engineering Technician III
Huntington Beach, CA
Contract
Onsite
Mid Level
3+ years expInvestigo is a medical device company focused on creating advanced artificial hearts. They are seeking a Manufacturing Engineering Technician III to support the development, improvement, and validation of assembly and test processes for Class III medical devices.
AccountingFinanceProfessional Services
Responsibilities
Supporting the development, improvement, validation, troubleshooting, and scaling of assembly, equipment, and test processes for a Class III medical devices
Set up, operate, and maintain production and test equipment in accordance with manufacturing instructions and quality standards
Support equipment qualifications (IQ/OQ/PQ), process validations, and test method validations
Perform routine maintenance and calibration to ensure optimal equipment performance
Troubleshoot and resolve equipment issues to minimize downtime
Build products in compliance with environmental controls, hygiene requirements, procedures, and work instructions
Develop and support assembly and test fixtures per approved documentation
Inspect incoming supplier components against quality inspection requirements
Test, inspect, and measure finished products, components, and devices to verify compliance with functional specifications
Troubleshoot, adjust, repair, and perform root-cause analysis on finished products and components
Assist in the development, optimization, and documentation of manufacturing processes
Support engineers in implementing process improvements to enhance efficiency, quality, and cost
Assist Quality and Purchasing teams with inventory tracking and documentation
Support the creation, modification, review, and execution of work instructions, assembly drawings, manufacturing processes, protocols, reports, records, and engineering change documentation
Conduct in-process and final inspections to ensure products meet quality and regulatory requirements
Document and report nonconformances and defects
Support failure analysis, root-cause investigations, and corrective and preventive actions (NCRs, CAPAs)
Maintain cleanroom and controlled-manufacturing environments in compliance with housekeeping, ESD, and 5S standards
Maintain accurate records related to equipment maintenance, calibration, and process changes
Ensure compliance with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP)
Provide technical support, training and collaborate with manufacturing operators, quality personnel, and production teams on equipment and processes
Identify opportunities for process, equipment, and workflow improvements
Participate in Lean Manufacturing, Six Sigma, and other continuous improvement initiatives as required
Qualification
Required
Associate degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or a related field; or equivalent hands‑on experience
3 years of experience in manufacturing, assembly, or production—preferably in medical devices, pharmaceuticals, or other regulated industries
Valid driver's license
Ability to work independently and collaboratively in a regulated environment
Perform light material handling tasks, including lifting up to 35 pounds for short durations
Ability to sit for extended periods, including 8+ hour shifts
Frequent keyboard and computer use
Willingness and ability to wear full cleanroom attire (gown, gloves, mask, etc.) for entire shifts
Company
Investigo
Investigo is offering accountancy, finance, audit, risk, compliance, property and facilities management services located in London.
201-500 employees
Funding
Current Stage
Growth StageRecent News
Bdaily Business News
2025-01-22
Company data provided by crunchbase