Medical Device Consultant

Medical Device Consultant – Manufacturing Engineering

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!

ABOUT THE POSITION

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 manufacturing engineering consultant, you will play a key role in the medical device projects by engaging with a wide range of stakeholders to ensure robust manufacturability of the medical devices, both early and late stage.

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.

  • Support design for manufacturing and assembly activities to ensure a robust design
  • Ensure alignment with subcontractors on quality and delivery from design to implementation
  • Conducting investigations to characterize the process and define requirements and specifications for process and equipment
  • Equipment verification and validation activities
  • Plan and execute the design transfer process
  • Plan and execute design verification tests
  • Support risk management and the definition of control measures
  • Perform systematic analysis of technical issues and create alignment with stakeholders to reach decisions and ensure progresss.

You will work in close collaboration with many different stakeholders for example regulatory affairs, risk managers, development engineers, project managers, procurement managers, external vendors and CMOs and will play an important role in creating alignment between these multi-disciplinary stakeholder

ABOUT YOU

Professional Competencies

  • Sc. and/or M.Sc. in relevant technical field
  • Experience within a similar position
  • Experience with medical device development and manufacturing
  • Experience with Design Controls, GMP and creating documentation
  • Fluent in both written and spoken English is required

Personal Profile:

  • Self-starter with personal drive
  • You like people and enjoy interacting with team members
  • Like new challenges and is not discouraged by uncertainties

WE OFFER

An exciting position in a company with a growth journey in which you can grow yourself – both professionally and personally, where you will be exposed to a wide range of different work assignments. Working as a consultant means you usually have a clearly defined task allowing you to focus on creating value and results.

 

For more details about the company or position, please contact André Hansen, Business Director – Medical Devices on +45 2666 7737 or e-mail Andre.Hansen@aptiogroup.com

Submit your resume using the below form – All applications must be submitted in English and are treated confidential.

ABOUT APTIO GROUP

Aptio Group consultancy is an agile & 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 EU.

Our office is placed in Hillerod, but our consultants are primarily working at customer facilities in Denmark and 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 SIGMA but powered directly by Danir Group.

Aptio Group’s success relies solely on our relations with our colleagues and clients. If you want to be a part of shaping the future of consultancy, then Aptio Group is the right place for you.

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