Manufacturing And Filed Service Engineer

Position Overview:

We are seeking a motivated and detail-oriented Manufacturing and Field-Service Engineer to join our dynamic team at Traferox Technologies, a leading medical device company.

In this role, you will be responsible for supporting various aspects of manufacturing, new product introduction, designing manufacturing jigs and fixtures, and client equipment filed servicing.

Your contributions will directly impact on the quality, efficiency, and reliability of our medical devices, ensuring they meet the highest standards and provide exceptional patient care.

Key Responsibilities:

1. Manufacturing Support:

• Participate in the design and optimization of manufacturing processes, workflows, and assembly methods to improve efficiency, reduce costs, and enhance product quality.
• Monitor production lines, identify potential bottlenecks or issues, and implement corrective actions as needed.
• Assist in the creation and maintenance of manufacturing work instructions, standard operating procedures (SOPs), and documentation.
• Design and develop manufacturing jigs, fixtures, and tooling to aid in the assembly and testing of medical devices.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure successful manufacturing operations.

2. New Product Introduction (NPI):

• Support the validation and verification activities for new products, ensuring they meet regulatory requirements and quality standards.
• Write IQ/OQ/PQ and execute new equipment validation and verification
• Collaborate with R&D and design teams to ensure seamless transfer of products from development to production.
• Participate in risk assessment and mitigation strategies during the NPI phase.
• Contribute to the NPI process by providing engineering expertise in the evaluation of new designs, prototypes, and components.

3. Client Equipment Filed Servicing:

• Act as a technical resource for clients by providing on-site servicing and maintenance of medical equipment, ensuring optimal performance and adherence to manufacturer specifications.
• Troubleshoot and diagnose technical issues related to medical devices, utilizing problem-solving skills and technical knowledge to resolve issues promptly.
• Conduct routine preventive maintenance and calibration of medical equipment at client locations.
• Train clients on proper usage, maintenance, and troubleshooting of equipment to ensure safe and effective operation.

4. Continuous Improvement:

• Actively participate in root cause analysis and corrective action implementation for any identified issues.
• Identify opportunities for process improvement, quality enhancement, and cost reduction within manufacturing and servicing activities.

5. Documentation and Compliance:

• Contribute to the preparation of technical reports, performance summaries, and documentation for regulatory submissions.
• Maintain accurate and up-to-date records of all manufacturing, NPI, and servicing activities, ensuring compliance with regulatory requirements.

Qualifications and mandatory job requirements:

• Bachelor's degree in Engineering (Mechanical, Biomedical, or related field).
• Effective communication and interpersonal skills for cross-functional collaboration and client interactions.
• Familiarity with medical device regulations (FDA, ISO 13485) and quality management systems.
• Willingness to travel to client sites for equipment servicing (estimated 10-30% travel).
• Excellent problem-solving skills and ability to troubleshoot technical issues.
• Strong understanding of manufacturing processes, quality standards, and NPI principles.

Preferred Skills:

• Basic programming skills for equipment calibration and diagnostics.
• Knowledge of SolidWorks (and PDM) CAD software for design evaluation and modification.
• Previous experience in a medical device manufacturing or servicing role.

Benefits:

• Positive and collaborative work environment focused on innovation and patient care.
• Exposure to cutting-edge medical device technologies and industry trends.
• Opportunities for professional growth and career advancement.
• Competitive salary and benefits package.