Engineering Technician

Summary: We are seeking a skilled and motivated Engineer technician to join our team in the medical device manufacturing field. The ideal candidate will be responsible for supporting design, developing, and optimizing processes, systems, and products to ensure compliance with regulatory standards and the highest quality levels. This role requires a strong technical background, problem-solving skills, and a commitment to advancing healthcare through innovative medical devices.

Key Responsibilities:

• Product Development and Design:
• Collaborate with cross-functional teams to design and develop new medical devices, ensuring compliance with industry regulations such as ISO 13485 and FDA 21 CFR Part 820.
• Perform design validation and verification activities to ensure products meet user needs and specifications.
• Manufacturing Process Optimization:
• Develop, evaluate, and improve manufacturing processes for efficiency, reliability, and scalability.
• Implement lean manufacturing principles and Six Sigma methodologies to enhance productivity and reduce waste.
• Quality Assurance:
• Conduct risk analysis, failure mode and effects analysis (FMEA), and root cause investigations to ensure product quality and safety.
• Collaborate with the quality team to implement corrective and preventive actions (CAPA) and ensure compliance with Good Manufacturing Practices (GMP).
• Regulatory Compliance:
• Ensure all processes, materials, and products meet applicable regulatory requirements and certifications.
• Prepare and maintain technical documentation to support regulatory submissions.
• Project Management:
• Lead or participate in projects related to product launches, process improvements, or technology transfers.
• Monitor project timelines, budgets, and deliverables to ensure successful execution.
• Equipment and Technology Management:
• Specify, procure, and validate manufacturing equipment and tooling.
• Troubleshoot and resolve technical issues in production lines and implement solutions to prevent recurrence.
• Collaboration and Training:
• Train production staff and other stakeholders on new processes, equipment, and quality standards.
• Work closely with R&D, supply chain, and operations teams to align goals and ensure smooth product integration.

Qualifications:

• Education:

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field.
Advanced degree or certifications (e.g., PMP, Six Sigma Green/Black Belt) is a plus.

• Experience:
• 3-5 years of experience in medical device manufacturing or a regulated industry.
• Hands-on experience with process validation, statistical process control (SPC), and technical documentation.
• Technical Skills:
• Proficiency in CAD software (e.g., SolidWorks) and data analysis tools (e.g., Minitab).
• Knowledge of materials science, assembly techniques, and manufacturing automation.
• Soft Skills:
• Strong problem-solving and analytical thinking.
• Excellent communication and team collaboration abilities.
• Detail-oriented with a commitment to quality and safety.

SALARY: 55k (flexible dependent on experience)

SHIFT: Standard 8-5

Job Type: Full-time

Pay: $24.08 - $26.44 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift

Ability to Commute:

• Mesquite, TX 75149 (Required)

Ability to Relocate:

• Mesquite, TX 75149: Relocate before starting work (Required)

Work Location: In person

Salary : $24 - $26