Principal Medical Device Design Transfer Specialist

2 days ago


Hørsholm, Hørsholm Kommune, Denmark Emply Denmark Full time

About the Role

As a Principal Medical Device Design Transfer Specialist, you will be responsible for leading design transfer activities within the medical device sector. You will work closely with R&D, Quality Assurance (QA), and suppliers to ensure seamless design transfers following established procedures.

Main Responsibilities

  • You will act as the primary technical resource for managing design transfer plans, reports, and qualification and validation activities for tools and high-volume production lines in the medical device industry.
  • You will develop process documentation and work instructions for clients, suppliers, and contract manufacturing organizations (CMOs).
  • You will review and generate production specifications, collaborating closely with R&D and quality teams to address production challenges during the development phase.
  • You will manage supplier relationships to ensure alignment with requirements and the ability to meet production standards.

Your Qualifications

  • You must have an MSc or BSc in Mechanical, Industrial, Manufacturing Engineering, or a related field.
  • You should have at least 3 years of experience in design transfer engineering for medical devices.
  • You should be familiar with risk management (manufacturing and suppliers), equipment qualification, and process validation.
  • You should have a good understanding of mechanics.
  • You should have strong communication skills and professional proficiency in English.

Benefits

  • This role offers an estimated salary of $85,000 per year.
  • You will work on a variety of projects for clients ranging from startups to industry leaders.
  • You will split your time between our Hørsholm office, client sites, and remote work.
  • You will be part of a well-established team at one of our larger, valued clients for an extended period.


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