Senior Design Transfer Engineer
Technolution
Are you passionate about bridging the gap between R&D and production within the medical device sector?
About the Role
As a Senior Design Transfer Engineer, you will take the lead on transferring medical device designs to production sites. You will work closely with R&D, Quality Assurance (QA), and suppliers to secure a correct and seamless transfer following established procedures where available and creating them where needed. Your strong sense for quality combined with your technical background and understanding of mechanics will be instrumental in minimizing risks, overcoming technical obstacles, contributing to process design, and ensuring accurate documentation throughout the process.
Key Responsibilities
- 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.
- Develop process documentation and work instructions for clients, suppliers, and contract manufacturing organizations (CMOs).
- Review and generate production specifications, collaborating closely with R&D and quality teams to address production challenges during the development phase.
- Manage supplier relationships to ensure alignment with requirements and the ability to meet production standards.
- As a consultant at Technolution, 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. For this specific role, we are seeking someone to join a well-established team at one of our larger, valued clients for an extended period.
Your Qualifications
- MSc or BSc in Mechanical, Industrial, Manufacturing Engineering, or a related field.
A minimum of 3 years of experience in design transfer engineering for medical devices. - Familiarity with risk management (manufacturing and suppliers), equipment qualification, and process validation.
- Good understanding of mechanics
- Strong communication skills and professional proficiency in English.
Additional Assets
- Knowledge of GMP and medical device industry standards.
- Experience with Six Sigma and other process improvement methodologies.
- Familiarity with automation and high-volume production techniques.
- Understanding of injection molding processes.
Want to know more
If you are intrigued and want to know more about this opportunity, you are welcome to reach out to Peder Skafte-Pedersen at [email protected].
How to apply
Feel free to skip the formal cover letter. Instead, we would appreciate a short relevant summary as part of your CV. No need to attach a photo - we prefer to see you when we meet.
Department: People & OrganizationDeadline: 31 January 2025
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