Vacant job

Do you want to help develop tomorrow's medical technology products and ensure that new products can be produced efficiently, robustly, and in compliance with regulatory requirements? We are looking for an experienced Production Engineer who wants to work closely with product development, production, quality, and suppliers to industrialize and improve manufacturing processes for medical technology products.

About the role

As a Production Engineer, you are responsible for the development, implementation, and optimization of manufacturing processes from product development to mass production. Among other things, you will:

• Participate in product development projects from a manufacturing perspective
• Develop and implement new production processes and production equipment
• Plan, execute, and document qualification of production equipment and process validation (IQ, OQ, PQ)
• Perform process risk assessments
• Ensure that processes meet requirements according to MDR, ISO 13485, and internal quality systems
• Work with deviation management and CAPA
• Drive change requests and technical improvement projects
• Develop and maintain production instructions, test methods, and technical documentation
• Collaborate with R&D, QA, RA, production, and external suppliers

Your background

We are looking for you who have a solid background in medical technology production or industrialization and are accustomed to working in regulated environments with high quality requirements. You have:

• An academic degree in medical technology, mechanical engineering, biotechnology, or equivalent
• At least 5 years of experience in production technology or process development within medical technology
• Practical experience with validation and qualification (IQ/OQ/PQ)
• Experience with deviation management, CAPA, and change control
• Experience with risk management in a production environment
• Good understanding of GMP, MDR, FDA, and ISO 13485
• Good proficiency in Swedish and English, both spoken and written

Personal qualities

As a consultant, you thrive in new environments and find it easy to build trusting relationships, both with colleagues and clients. You take responsibility for your work, are curious, and have the ability to see the big picture. To succeed in this role, we see that you are analytical and structured.

Together Tech for sustainable product development At Together Tech, you get the opportunity to contribute to the development of advanced medical technology products at some of the industry's most exciting companies. Through our client assignments, you will work closely with technology, quality, and innovation while developing yourself together with engaged colleagues.

Your development & our support 🌱 We care about both your development and well-being and offer among other things:

• Secure employment with collective agreement
• Wellness allowance of 4,000 SEK per year plus discounts on training activities
• Social team activities – from afterworks to sports activities
• Individual development plans and opportunities for courses in areas such as sustainability
• A company that for three years in a row, 2024, 2025 & 2026, has been named one of Sweden's most attractive employers by Karriärföretagen 🌟

Want to know more about us? Visit our website at www.togethertech.com (http://www.togethertech.com)

For questions regarding the position, please contact HR Manager Sofia Nilsson via email or phone at 0737-17 94 38.