Job Description
Position Overview:
We are seeking a motivated and detail-oriented Mechanical Design and Manufacturing 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 clients’ 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. Sustaining Engineering and Manufacturing Support:
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure successful manufacturing operations.
- Participate in the design and optimization of manufacturing processes, workflows, and assembly methods to improve efficiency, reduce costs, and enhance product quality.
- Design and develop manufacturing jigs, fixtures, and tooling to aid in the assembly and testing of medical devices.
- 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.
2. New Product Introduction (NPI):
- Contribute to the NPI process by providing engineering expertise in the evaluation of new designs, prototypes, and components.
- Collaborate with R&D and design teams to ensure seamless transfer of products from development to production.
- 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
- Creating manufacturing process maps and process failure mode and affect analysis (PFMEA)
- Participate in risk assessment and mitigation strategies during the NPI phase.
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:
- Identify opportunities for process improvement, quality enhancement, and cost reduction within manufacturing and servicing activities.
- Actively participate in root cause analysis and corrective action implementation for any identified issues.
5. Documentation and Compliance:
- Maintain accurate and up-to-date records of all manufacturing, NPI, and servicing activities, ensuring compliance with regulatory requirements.
- Contribute to the preparation of technical reports, performance summaries, and documentation for regulatory submissions.
6. Qualifications:
- Bachelor’s degree in engineering (Mechanical, Biomedical, or related field).
- 5-8 years of experience in Mechanical Design, manufacturing engineering, and field servicing, ideally in medical devices
- Strong understanding of manufacturing processes, quality standards, and NPI principles.
- Familiarity with medical device regulations (FDA, ISO 13485) and quality management systems.
- Excellent problem-solving skills and ability to troubleshoot technical issues.
- Effective communication and interpersonal skills for cross-functional collaboration and client interactions.
- Willingness to travel to client sites for equipment servicing (estimated 10-30% travel).
7. Preferred Skills:
- Knowledge of SolidWorks (and PDM) CAD software
- Knowledge in creating manufacturing process maps and process failure mode and affect analysis (PFMEA)
- Basic programming skills for equipment calibration and diagnostics.
8. Benefits:
- Competitive salary and benefits package.
- Opportunities for professional growth and career advancement.
- Exposure to cutting-edge medical device technologies and industry trends.
- Positive and collaborative work environment focused on innovation and patient care.
Job Tags