Design Control & Sourcing Engineer, Mediplast

Join the team at Mediplast in Malmö 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 the manufacturing suppliers, be involved in manufacturing, change management, as well as maintenance and replacement planning, ensuring that Mediplast 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

About you

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

Application process

In this recruitment, Mediplast is collaborating with Mpya Sci&Tech. Submit your application directly via our website www.mpyascitech.com no later than November 30th. We work with ongoing selection, so don't hesitate to apply as the position may be filled before the application deadline. If you have any questions about the role, you are warmly welcome to contact Talent Advisors Erik Düring, +46 70-899 94 69, [email protected], or Shuhad Choudhury, +46 73-148 98 58, [email protected]

About the company

Mediplast is part of AddLife group, listed on NASDAQ Stockholm, and shares their vision of improving people’s lives by being a leading, value-creating player in Life Science. As a member of this larger MedTech family, we can provide you with additional consulting and services, as well as product training. As a company producing and distributing medical solutions, sustainability is ingrained in our DNA. We recognize the importance of sustainability and our role in ensuring the long-term viability of our planet and its resources. We are mindful in our use of resources and respectfully implementing sound governance practices and complaint behaviour across our organization. We embrace and drive ESG principles in all aspects of our operations. At Mediplast we recognize the importance of fostering positive social impact and maintaining strong relationships with our employees, customers, and communities. We strongly believe in fostering a culture that is characterized by humility, helpfulness, personal ownership, and respect amongst each other. By committing to a profound human approach internally, we are convinced that this also mirrors our interactions and relationships with our external stakeholders. We believe this is the reason why we are seen as a trusted and engaged partner with a genuine care for people.

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.

Seize the opportunity and apply for this position at a prominent MedTech company!