Biograil is looking for an experienced Engineer or alternatively similar proven experience within the medical device or pharmaceutical industry and with a technical flair and thrive to solve technical problems. You like the combination of hands-on development of technical solutions and working with external parties as well as brainstorming sessions and execution of ideas. You like to work independently and in a small team with a common goal and to have a big responsibility and take decisions as well as a “go do” mentality.
We can offer an innovative workplace with a lot of room for own development and personal growth. You will work closely with the founders and the executives and be an integral part of a small energetic team.
Roles and Responsibilities:
- Part of Biograil Manufacturing Development Department reporting to Manufacturing Director Martin Rex Olsen.
- Responsible for Manufacturing Design Development
- Device design for Manufacturing in collaboration with the technology team
- Support the design control process including development of user requirements and device specifications
- Development of automation solutions for clinical testing and in preparation for late-stage manufacturing
- Participate in the selection and qualification of external suppliers
- Support engineering tasks related to external collaborations
- 3D modeling of automation solutions, device designs etc.
- Generate manufacturing and technical data to support specifications and quality with systematic documentation and reporting for regulatory purposes
- Support project planning and execution of internal projects and support prioritization discussions
- Support and work on the development of Biograil e-QMS solution and adhere to agreed standard operating procedures. This includes preparation and review of SOPs and instructions
- Provide technical update input to management verbally and in writing
Candidate:
You have a solid technical background in the medical device/pharma industry or alternatively in the plastic industry with understanding of the regulations and requirements in the med-tech industry. You have experience with 3D CAD modelling, preferably SolidWorks.
You like working in a dynamic and changing environment but are able to maintain a good systematic structure in your daily work.
Biograil is using a large number of external supplier and have a number of external collaborations, and therefore, it is important that you enjoy communication and collaboration with external parties.
If you are interested in this role, please contact Biograil at info@biograil.com.
Biograil is currently located on Langebjerg 1, 4000 Roskilde, next to Holbækmotorvejen and Roskilde and Trekroner Train Station.
Biograil ApS is a start-up company founded in 2019. We are developing a small device fitting into a standard-sized capsule for effective delivery of biologics via the oral route as an alternative to injections. As the technology is unique, we are developing our own in vitro test systems to optimize prototypes of the technology. We are working with collaborations being the best in their field to make this technology with almost unlimited potential if it becomes a success.