What are the responsibilities and job description for the Manufacturing Engineer (Medical Device) position at Tek Support?
The Manufacturing Engineer will work closely with cross-functional teams to optimize production processes, improve manufacturing efficiency, and ensure the highest standards of quality in the production of medical devices. The successful candidate will contribute to the design, improvement, and troubleshooting of manufacturing processes to meet regulatory and quality standards while maintaining a focus on operational excellence.
Key Responsibilities:
- Develop, implement, and maintain manufacturing processes for medical devices.
- Analyze production workflows, identify inefficiencies, and drive continuous improvement initiatives.
- Work with design teams to provide feedback on product designs for manufacturability.
- Troubleshoot and resolve technical issues in production.
- Ensure compliance with regulatory standards, including FDA and ISO requirements.
- Collaborate with quality assurance and product development teams to ensure the highest standards of product quality.
- Support the creation and review of manufacturing documentation (SOPs, work instructions, etc.).
- Participate in the validation and qualification of new equipment and production lines.
- Conduct root cause analysis and implement corrective actions for non-conformances.
Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Manufacturing, Industrial, or related field).
- At least 2 years of experience in a manufacturing engineering role, preferably in the medical device industry.
- Strong knowledge of lean manufacturing principles and continuous improvement methodologies.
- Experience with CAD software and other manufacturing tools.
- Understanding of regulatory standards (FDA, ISO, etc.).
- Strong problem-solving skills and attention to detail.
- Excellent communication skills and ability to work in a team environment.
