Are you looking for a new challenge, and do you want to support our customers in developing complex products within Medical Device and Combination Products? If so, Aptio Group wants to meet you!
You will become a consultant in our business unit Medical Device and Combination Product with the potential of supporting a wide range of projects within product and manufacturing development.
As a System Engineering Consultant, you will play a key role in the medical device projects by managing device requirements and specifications, driving Design Controls activities, and creating alignment between different stakeholders throughout the development phase. You should be able to have both a detailed and holistic overview of the development process and Design Controls deliverables allowing you to guide the establishment of the design history file documentation and handle technical or compliance issues. As such, you have a flair for coordination and driving progress.
Projects are executed in very close collaboration with the customers, where you as a consultant will work as an integrated part of the development team. It is therefore important that you are a team player, service-minded and able to ensure alignment with the people you work with.
Responsibilities can vary from project to project but is expected to fall within the following:
- Definition and breakdown of design input requirements in collaboration with stakeholders
- Support the risk management and human factor engineering process
- Contribute to the establishment of the design history file documentation and support with Design Controls and regulatory submissions
- Establish and maintain product specifications
- Planning and documentation of device verification testing
- Support manufacturing development and the design transfer process
- Collaboration with external vendors e.g., regarding change management, handling of quality issues or updating documentation
- Facilitate systematic analysis of technical or compliance issues and create alignment with stakeholders to reach decisions and ensure progress
- B.Sc. and/or M.Sc. in a relevant technical field
- Experience within a similar position
- Experience with medical device development and manufacturing
- Experience with Design Controls and documentation, working with both internal and external parties such as vendors and CMOs
- Fluent in both written and spoken English is required
- Self-starter with personal drive
- Like being around people and enjoy interacting with team members
- Fond of new challenges and is not discouraged by uncertainties
- Private health insurance
- Good pension plans
- Paid overtime
- Subsidised fitness and sports
- EU work permit