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Design Control Specialist

1 month ago


Malmo, Skåne, Sweden Mediplast Full time
About the Role

We are seeking a highly skilled Design Control Specialist to join our team at Mediplast in Malmö. As a key member of our cross-functional team, you will play a crucial role in ensuring our medical devices meet end-user expectations, design control standards, and regulatory requirements.

Key Responsibilities
  • Lead the design transfer of products from development to manufacturing
  • Compile and manage design reviews
  • Develop and write test protocols and reports
  • Compile and analyze data to deliver recommendations for device and production improvement
  • Create, communicate, and execute plans to meet applicable deadlines
  • Improve production methods and enable sustainable production
  • Manage quality assurance matters related to production processes
  • Document production processes
About You

We are looking for a candidate with a proven ability to compile and analyze data, alongside a solid understanding of medical device regulatory requirements related to design, development, and production activities. You should be structured and accustomed to planning and following up on activities, with experience in independently initiating and driving activities. Collaboration with stakeholders, listening to and understanding their needs, translating requirements, and effectively communicating and collaborating to achieve project goals are essential skills for this role.

  • A minimum of a Bachelor's Degree in Life Sciences or Engineering discipline combined with 5+ years medical device product development/manufacturing experience
  • Higher level qualification in medical device technology an advantage but not essential
  • Experience in CAD for drawings and assemblies is desirable
  • Knowledge in regulatory standards / regulations (ISO13485, MDR, or similar)
  • Fluent in Swedish and English, both written and spoken
What We Offer

As a Design Control Specialist at Mediplast, you will be part of a dynamic team that is committed to improving people's lives through medical solutions. We offer a collaborative and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.

Apply now and take the first step towards an exciting career opportunity at Mediplast