Medical Device Design Control Specialist

7 days ago


Malmo, Skåne, Sweden Mediplast Full time
About the Role

We are seeking a highly skilled and experienced Medical Device 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, safety, 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
  • Compile and analyze data to deliver recommendations for device and production improvement
  • Collaborate with cross-functional teams to drive design, development, and production activities
Requirements
  • Minimum of 5+ years of experience in medical device product development and manufacturing
  • Strong understanding of medical device regulatory requirements, including ISO 13485 and MDR
  • Experience with CAD for drawings and assemblies
  • Fluent in Swedish and English, both written and spoken
What We Offer

As a Medical Device Design Control Specialist at Mediplast, you will have the opportunity to work on a wide range of medical devices and contribute to the development of innovative products that improve patient outcomes. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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