Senior Process Development Lead

5 hours ago


Malmo, Skåne, Sweden Nordberg Medical AB Full time
Job Description:

We are seeking a highly skilled Senior Production Process Engineer to join our team at Nordberg Medical AB. As a key member of our production team, you will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our implantable Class III medical devices.

This role involves collaborating with cross-functional teams to implement advanced manufacturing techniques, supporting scaling up projects, improving efficiency and product quality, and driving continuous improvement initiatives. You will play a crucial role in problem-solving and troubleshooting production issues while ensuring compliance with regulatory standards.

The ideal candidate will have around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with a strong understanding of GMP, ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements. A bachelor's degree in engineering or a related field is required, with a master's degree being a plus.

You will be based at our CMO site in Malmö and be required to travel to our HQ in Stockholm from time to time. The role will involve occasional travel to supplier sites or other company locations as required.



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