Design Control Specialist

1 month ago


Malmo, Skåne, Sweden Mediplast Full time
About the Role

We are seeking a highly skilled and experienced Design Control Specialist to join our team at Mediplast. As a key member of our product development team, you will be responsible for ensuring that our medical devices meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Lead the design transfer of products from development to manufacturing
  • Compile and manage design reviews to ensure compliance with regulatory requirements
  • Develop and write test protocols and reports to validate device performance
  • Analyze data to identify areas for improvement and develop recommendations for device and production optimization
  • Collaborate with cross-functional teams to ensure seamless design control processes
Requirements
  • Bachelor's degree in Life Sciences or Engineering discipline
  • Minimum 5+ years of experience in medical device product development and manufacturing
  • Strong understanding of regulatory standards and requirements (ISO13485, MDR, etc.)
  • Excellent communication and collaboration skills
  • Fluency in Swedish and English, both written and spoken
About Mediplast

Mediplast is a leading player in the Life Science industry, committed to improving people's lives through innovative medical solutions. We value sustainability, social responsibility, and a culture of humility, helpfulness, and respect. If you share our values and are passionate about medical device development, we encourage you to apply for this exciting opportunity.



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