Position Title: Technician Work Location: Plano, TX 75024 Assignment Duration: 12 Months Work Schedule: 6:00 AM - 4:30 PM Work Arrangement: Onsite Position Summary:
- Set up, calibrate, and operate basic manufacturing equipment in accordance with production schedules and quality standards.
- Assemble electromechanical subassemblies and finished medical devices, including handling small precision components.
Key Responsibilities:
- Set up, calibrate, and operate basic manufacturing equipment in accordance with production schedules and quality standards.
- Assemble electromechanical subassemblies and finished medical devices, including handling small precision components.
- Perform functional and electrical testing using automated equipment and manual instruments (oscilloscope, multimeter, function generator).
- Troubleshoot technical issues related to product lines and manufacturing processes to minimize defects; escalate complex issues as needed.
- Conduct electrical testing of medical device hardware in compliance with regulatory and quality standards.
- Support rework, repair, servicing, and refurbishment of nonconforming products.
- Perform routine and preventive maintenance on production equipment; document activities in CMMS (InforEAM).
- Maintain accurate production and quality documentation, including Device History Records (DHR), ensuring traceability and compliance.
- Utilize electronic systems and software tools for data collection and production tracking.
- Adhere strictly to FDA regulations, Quality Management System (QMS), and Environmental Health & Safety procedures.
- Support engineering initiatives such as process validation, continuous improvement, and new product introduction (NPI).
- Identify opportunities to improve manufacturing efficiency, yields, and productivity.
- Manage priorities across multiple product lines with minimal supervision.
- Provide cross-functional support and training to team members as needed.
- Communicate effectively with manufacturing, engineering, and quality teams.
- Interpret technical documents including SOPs, work instructions, and engineering drawings.
- Support audits, inspections, and collaborate with internal teams, vendors, and contractors.
Qualification & Experience:
- Typically 0-2 years of relevant manufacturing or production experience (medical device or regulated industry preferred).
- Electromechanical assembly
- Troubleshooting and problem-solving
- Electrical testing and inspection
- Use of test equipment (oscilloscope, multimeter, etc.)
- Attention to detail and documentation accuracy
- Ability to follow SOPs, drawings, and technical instructions
- Knowledge of GMP/FDA-regulated environments
- Computer/data entry skills
- Medical device or highly regulated manufacturing environment
- Experience with cleanroom operations
- Familiarity with CMMS systems (InforEAM)
- Exposure to QMS, EMS, and compliance standards
- Continuous improvement or lean manufacturing experience
Education & Certifications
- High school diploma or GED required
- Technical certification or associate degree in electronics, manufacturing, or related field preferred
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