Project Engineer
2 weeks ago
˚MEQU Copenhagen, Capital Region of Denmark, Denmark
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Project Engineer for Research & Development at °MEQU
Join a fast-growing MedTech scaleup
Join °MEQU as we embark on an exciting growth journey and seek a new Project Engineer for our Research & Development (R&D) Department.
Seize this opportunity if you want to be part of our dynamic team in Copenhagen and help us develop medical devices, shaping the future of critical care.
At °MEQU we empower healthcare professionals to combat hypothermia and save lives with our innovative °M Warmer System; a portable blood and IV fluid warmer that heats fluids to body temperature within seconds. Used by military forces, emergency medical services, rescue helicopters, and hospitals globally, our system is trusted in the most demanding environments. We achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024. As we continue our growth and expand into new markets, we are committed to delivering cutting-edge, user-friendly healthcare solutions.
The company complies with the following overall Quality Management System Medical Device Requirements: ISO 13485:2016, ISO 14971:2019 Risk Management according to MDD/MDR, FDA.
We have offices at Symbion, Fruebjergvej 3, 2100 Copenhagen.
The role you will fill
As our new Project Engineer, you will be part of R&D and report to the Manager of R&D in Mequ. The position is a part of an exciting expansion supporting our commitment to continuous innovation and growth. You will play a key role in ensuring technical excellence and compliance in our development of medical devices.
THE POSITION
As our new Project Engineer, you will:
- Be responsible for driving 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.
- Ensure that work is conducted in compliance with MEQU QMS.
ABOUT YOU
You have several years of experience from a position in R&D, ideally from a company within the Medtech business. You are now ready to join a young and vibrant MedTech scale-up and take part in a fast-paced expansion phase.
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.
- Are motivated by working in a scale-up company with a wide range of challenges.
- Enjoy working independently, testing and documenting new things and processes, and navigating a workday with shifting priorities and tight deadlines.
- It will be an advantage if you, from your previous positions, have gained knowledge working with a broad range of technical areas, such as mechanics, plastic, electronics, and software.
Mequ is characterized by a strong culture of cross-functional collaboration and a striving to optimize working processes. You will work closely with colleagues in RA/QA, Operations and Sales/Marketing.
APPLY
An external HR Specialist will be involved in the recruitment process.
Send your CV and application to nm@nilsmunck-consult.com.
For more information about the recruitment process contact: Nils Munck, +45 53573274.
For questions related to the position, contact Tora Hedeager, +45 61436630.
We kindly ask you to apply as soon as possible: we will be conducting interviews with candidates on an ongoing basis.
Seniority level- Mid-Senior level
- Full-time
- Engineering and Information Technology
- Medical Equipment Manufacturing
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