Job Overview
* Lead the development of innovative manufacturing processes through rigorous testing and validation.
* Collaborate with cross-functional teams to design, implement, and optimize process designs that meet quality and regulatory requirements.
* Drive process qualification and validation efforts to ensure compliance with ISO 13485 Quality Management System standards.
* Develop and maintain technical documentation, including process instructions and technical reports.
* Provide guidance and support to junior engineers and technicians in process development and validation activities.
* Stay up-to-date with industry developments and emerging trends in medical device manufacturing and materials science.
Requirements:
* Master's or Doctoral degree in Engineering or a related field.
* At least 5 years of experience in product development and process validation within the medical device industry.
* Strong background in catheter technologies, including reinforced (braided and coiled) and steerable polymer shafts.
* Excellent problem-solving skills and ability to work effectively in a team environment.
* Proficient in Microsoft Office and MS Project.
* Good understanding of medical device regulations and quality systems.
Key Skills:
* Engineering degree
* Medical device industry experience
* Process development and validation
* Catheter technologies
* Problem-solving
* Teamwork
* Microsoft Office
* Quality management