Back to jobs

Manufacturing Engineering Technician III

Job description

Position Overview
The Manufacturing Engineering Technician is a hands-on role responsible for supporting the development, improvement, and scaling of assembly and test processes for a Class III medical device. This position serves as a critical link between design and production by supporting process validations, maintaining and troubleshooting equipment, documenting manufacturing processes, and assisting with pilot and low-volume manufacturing operations.
The role requires strong technical aptitude, attention to detail, and a quality-focused mindset. The Manufacturing Engineering Technician works closely with cross-functional teams including Mechanical, Electrical, Biomedical Engineering, Quality, and Operations to support the delivery and scale-up of a regulated medical device in a fast-paced environment. This position requires the ability to work independently with minimal supervision.
Key Responsibilities
This job description reflects the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities.
Equipment Maintenance and Calibration
  • 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.
Process Support
  • Assist in the development, optimization, and documentation of manufacturing processes.
  • Support engineers in implementing process improvements to improve 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.
Quality Assurance
  • 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.
Documentation and Compliance
  • Maintain accurate records related to equipment maintenance, calibration, and process changes.
  • Ensure all activities comply with FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP).
Collaboration and Training
  • Collaborate closely with manufacturing engineers, quality personnel, and production teams to support daily operations.
  • Provide technical support and training to manufacturing operators on equipment and processes.
Continuous Improvement
  • Identify opportunities for process, equipment, and workflow improvements.
  • Participate in Lean Manufacturing, Six Sigma, or continuous improvement initiatives as required.
Qualifications, Knowledge, and Experience
Education and Experience
  • Associate degree or certification in Engineering Technology, Mechanical Engineering, Biomedical Engineering, or a related field; or equivalent hands-on experience.
  • Minimum of 3 years of experience in manufacturing, assembly, or production, preferably in medical devices, pharmaceuticals, or other regulated industries.
Skills and Competencies
  • Strong ability to follow detailed procedures and accurately document work.
  • Solid understanding of manufacturing processes and quality systems.
  • Strong verbal and written communication skills.
  • Ability to work independently and collaboratively in a regulated environment.
Physical Requirements
  • Ability to perform light material handling tasks, including lifting up to 35 pounds for short durations.
  • Ability to sit for extended periods, including shifts of 8 hours or more.
  • Frequent keyboard and computer use.
  • Willingness and ability to wear cleanroom attire (gown, gloves, mask, etc.) for the duration of assigned shifts.