Technical Lead for Medical Device Development
1 week ago
At °MEQU, we empower healthcare professionals to combat hypothermia and save lives with our innovative °M Warmer System.
Our portable blood and IV fluid warmer heats fluids to body temperature within seconds, trusted in demanding environments globally.
We achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024, committed to delivering cutting-edge, user-friendly healthcare solutions.
The RoleAs our new Project Engineer, you will be part of R&D and report to the Manager of R&D in Mequ.
You will play a key role in ensuring technical excellence and compliance in our development of medical devices.
- Drive technical implementation of product changes/improvements along with validation and verification activities based on statistical data.
- Write technical protocols according to requirements for product testing.
- Conduct product testing and ensure fulfillment of criteria and requirements.
- Foster a collaborative and motivating team environment to drive project success.
- Ensure project execution and coordination across disciplines and departments in the organisation.
- Ensure compliance with international standards including ensuring delivery of all documentation.
You have several years of experience from a position in R&D, ideally from a company within the Medtech business.
We expect that you:
- Hold a M.Sc. in Engineering background within the field of mechanics, electronics or materials and manufacturing engineering.
- Have 2-4 years of experience from a project engineer position within medical device development, with a strong understanding of the relevant compliance requirements and documentation.
- Are a strong collaborator who actively engages in project work and coordination across disciplines and departments in the organization to achieve common goals.
- Will work responsibly and deliver according to agreed deadlines.
- Will take responsibility, work proactively, and ensure deliveries following agreed structures, procedures and systems.
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