Design Control & Sourcing Engineer

Join our team as an important contributor to the development and improvement of medical devices within the Mediplast Own Brand portfolio. In this role, you will work with a cross-functional team to ensure our products meet end-user expectations, design control standards, and regulatory requirements.

Reporting to the Sourcing Manager, you will be involved in the different stages of device development and production. Your responsibilities will include driving change activities, managing device documentation updates, and participating in verification and validation activities. You will also, in cooperation with our manufacturing suppliers, be involved in manufacturing, change management, as well as maintenance and replacement planning, ensuring that our products remain effective and reliable.

Main tasks & responsibilities:

In this role, you will be involved in the design, development, testing, and manufacturing of medical device products. You will perform and document Design Verification and Design Validation, ensuring that all processes meet quality and regulatory requirements. Your responsibilities will include planning and driving activities/projects that cover design, development, design control, design transfer, and production activities.

• Lead the design transfer of products from the development stage 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.
• Improving production methods and enabling sustainable production
• Manage quality assurance matters related to production processes
• Documentation of production processes

In this role, you will leverage your proven ability to compile and analyze data, alongside a solid understanding of the fundamentals of medical device regulatory requirements related to design, development, and production activities. You are structured and accustomed to planning and following up on activities, with experience in independently initiating and driving activities. Working cross-functionally, you will collaborate with stakeholders, listening to and understanding their needs, translating requirements, and effectively communicating and collaborating to achieve project goals. Knowledge in materials and materials science, as well as design and development experience, is a great advantage in this role. Experience in design transfer from R&D to manufacturing, and a strong background in the design verification and validation process is also desirable.

• 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

For us, it is important that you contribute to a healthy culture that is characterized by humility, helpfulness, respect, great personal ownership and always with a clear focus on the patient and healthcare professionals.

We are collaborating with Mpya Sci & Tech, and candidates are kindly requested to contact Erik Düring at +46708-999469 or erik.during@mpyascitech.com for more information.