Manufacturing Engineer

As we continue to expand our operations, we are seeking a talented and driven Manufacturing Engineer to join our team.

Responsibilities:

• Design, develop, and optimize manufacturing processes and systems to produce catheters in accordance with regulatory requirements and industry standards.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Operations, to support new product development and introduction (NPI) activities.
• Conduct feasibility studies, process validations, and risk assessments to ensure the manufacturability and scalability of new products.
• Implement continuous improvement initiatives to enhance productivity, reduce costs, and improve quality in manufacturing operations.
• Lead root cause analysis and problem-solving efforts to address process deviations, non-conformances, and quality issues.
• Generate and maintain comprehensive documentation, including manufacturing procedures, work instructions, and process validations.
• Stay current on industry trends, technological advancements, and regulatory changes relevant to medical device manufacturing.

Qualifications:

• Bachelor’s degree in mechanical engineering, Industrial Engineering, or a related field.
• Minimum of 2 years of experience in manufacturing engineering, preferably in the medical device industry.
• Strong knowledge of manufacturing processes, materials, and technologies, including machining, injection moulding, and assembly.
• Experience with process validation, statistical analysis, and quality management systems (e.g., ISO 13485, FDA QSR).
• Excellent analytical and problem-solving skills, with the ability to lead cross-functional teams and drive results.
• Effective communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.