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.

MAIN RESPONSIBILITIES

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

Job requirements

Professional Competencies:

  • 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

Personal Profile:

  • 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

Benefits

  • Private health insurance
  • Good pension plans
  • Paid overtime
  • Subsidised fitness and sports

Job restrictions

  • EU work permit
Job details
Work experience:
Work experience is not required
Language skills:
  • English
  • Fluent
Number of positions:
1
Date of expiry:
About company

Aptio Group is an agile and innovative Life Science Consulting Company built on a simple business model leading to efficient deliveries of our services. We employ specialized Life Science Consultants working with the largest pharma and biotech companies in Denmark and the EU. Our headquarters is placed in Hillerød, but our consultants are primarily working at customer sites in Denmark and the EU. Originally, Aptio Group was part of the leading consulting group, SIGMA in Sweden, founded in 2016, and then expanded to Denmark in late 2018. Today, we are no longer part of SIGMA but powered directly by Danir Group. Aptio Group’s success relies solely on our relations with our colleagues… Read more