About UNEEG medical A/S
UNEEG medical A/S is an entrepreneurial and ambitious company specializing in providing the epilepsy community with more accurate knowledge of seizures to support improvement in epilepsy care. UNEEG medical has created a tiny implant (class III) that monitor and analyse brain activity (EEG) to convey relevant information for epilepsy management. Their unique subcutaneous EEG solution was launched, and CE marked in 2019. The solution can be used for management and aid in diagnostics within epilepsy hence aiming at improving patients’ quality of life.
UNEEG medical employs approximately 85 people in a start-up culture. The company has initiated an international market launch, which requires several new functions and competencies over the coming years. UNEEG medical A/S is owned by TW Medical A/S (formerly known as the Widex Group) and is therefore well-funded.
Read more at www.uneeg.com
The situation
The exciting journey is just beginning with establishing a new field in epilepsy with ground-breaking technology. Ultra-long-term EEG monitoring has so far not been an option for epilepsy patients and the potential for both management and research is being unfolded with the use of this new solution.
The solution comprises of implant, external recorder, data infrastructure and algorithm SW and is currently being sold to and used by leading centres in epilepsy in EU (e.g., King’s College London, Filadelfia DK.).
UNEEG medical is present in 6 EU countries with some local sales offices in place. An FDA approval process is progressing with clinical trials and is expected to be finalized within the next 2-3 years.
UNEEG medical is looking for a Production Process Engineer (PTA) as we are currently preparing for wider distribution of our solution 24/7 EEG SubQ. Reporting to the Head of NPI & Production Engineering
you will play a key role in creating clarity and structure in manufacturing documentation as we are maturing our production set-up for current and future products.
Development and Operations
The Production Engineer role is placed in our new NPI (New Production introduction) team with high ambitions and expecting to grow as an organisation. Development and Operations are highly integrated in the organisation facilitating a strong collaboration around developing and maturing for scaling new product introductions and manufacturing/operations. The Development and Operations department consists of 50 headcounts including this role. There are only a few employees in operational roles, and they are also managing a close cooperation with subcontractors as these are necessary in order to deliver a complex technology.
The manufacturing processes involve contract manufacturing in EU and US on the mechanical end electronical parts of the class III device.
Your role
As Production Process Engineer you will be managing and controlling changes to the required documentation in production. You will play a key role in developing smooth and efficient processes as well as taking part in various projects regarding new products according to 1SO13485.
You will join our new NPI (New Product Introduction) team working closely cross functionally, influencing your tasks and the role as such.
This a role offering a unique possibility to build and shape the best processes and necessary documentation with a high degree of autonomy and influence.
You can build on your medtech experience and help us on our journey to produce at a larger scale.
In summary, your role will include:
- Participation in R&D development projects
- Design transfer activities from projects to production (internal production and through sub-suppliers)
- Creations of work instructions and processes for production (preparation, testing, configuration, and packaging)
- Responsible for NPI’s tasks in ECO’s including coordination with suppliers regarding outsourced processes
- Participation in documentation restructuring to fit our coming ERP implementation
- Development og current documentation and processes
Ideal candidate profile
As a candidate, you can come from a variety of roles and work experience within MedTech to take on this broad and interesting role. The most important skill for the role is experience with creating documentation and work instruction in a production setting. You should be motivated by taking the company to the next level of expansion making a significant difference for clinicians and patients. You should also thrive in a start-up/scale up like culture – a friendly and learning environment, where you get to take ownership and develop your role as the company develops.
In summary, your background should include:
- Experience with MedTech industry
- On hand experience with design transfer to production, including preparation of work instructions and process descriptions
- Knowledge of quality management systems (ISO13485)
- Preferably experience with medical devices containing electronics
- Hands-on experience with design transfer to production including preparation of work instructions and process description
- Knowledge of QMS systems, specially ISO13485
- Experience with execution of ECO’s (Engineering change-order process)
- Fluency in English written and spoken
- Relevant bachelor’s degree or master’s degree
- A structured and systematic approach with a good overview and doing multiple tasks simultaneously
- Seeking the pragmatic and good enough solution to keep us moving forward
- Being a team player proactively seeking knowledge also taking responsibility
- Strong collaboration and communication skills with an open mind but also comfortable voicing your opinions
- Being curious and fast learner of new complex products and technologies
- Positive with a good sense of humour
Why you should join UNEEG medical A/S
An entrepreneurial, purpose driven and fast-growing international company with Danish headquarters with a flat and informal collaborating culture with a long-term strategic focus for helping a patient group in high need of solutions to improve quality of life.
Good career possibilities alongside the company’s expansion.
The role is based in Allerød, DK
How to come into consideration
Please contact: Partner at Peoplement, Anne Borgen, either by mail: anne@peoplement.dk or phone +45 61690101 for more information.
