R&D ENGINEER, GOTHENBURG – SWEDEN

ABOUT THE ROLE

Integrum is a rapidly expanding MedTech company on an exciting and challenging growth
journey, where your contribution will make a difference. You will work with unique products
that change people’s everyday life.
We are currently looking for a R&D Engineer to lead research and product development
projects, and initiatives in all our product ranges. The technology and development focus
include activities from conceptualization of new products to final product on the market. In
the role you are part of a strong team of engineers and you report to the R&D Manager.
The ideal candidate is solution oriented and curious, structured and reliable in delivering
results. You are a proactive team player and able to combine engineering, regulatory and
quality requirements. Someone who likes challenges and to manage change.

 

KEY RESPONSIBILITIES

  • Develop and maintain company regulatory strategy
  • Maintain and improve QMS effectiveness and suitability
  • Being responsible for regulatory compliance
  • Line manager QA/RA team
  • Implement and plan projects, organize project teams, communicate with internal and external contacts
  • Monitoring new regulatory requirements as well as changes to existing regulations on worldwide basis
  • Secure regulatory requirements and documentation
  • Plan and perform regulatory submissions and updates worldwide to achieve market access
  • Contact and coordination with authorities both nationally and globally

YOUR BACKGROUND AND COMPETENCIES

We are looking for candidates with an experience from research and product development
preferably in the MedTech industry, minimum 3 years. You have a M Sc degree in
Mechanical Engineering, Biomedical Engineering or equivalent. You also have a good
understanding of the medical device regulations and related standards (ISO 13485, QSR,
MDD/MDR and ISO 14971) together with experience from CAD systems (Creo is an
advantage).
In this role you will need the freedom to travel, both domestic and internationally, together
with excellent communication skills in both Swedish and English.

WHAT WE OFFER

When joining our company, you will be working among experienced colleagues in a rapidly
growing environment. At Integrum, you will get the possibility to learn new exciting tasks and
enjoy constant personal and professional growth.
We are also looking for a Senior R&D Engineer with a minimum of 10 years experience,
please find link to ad here.

APPLICATION

To apply for this position please submit your CV and cover letter via jerrie.se, no later than
January 10. We will be starting interviews before this date so please don’t hesitate to forward
your application as soon as possible.

About Integrum

Integrum AB is a world leader in this area, and patients are being treated in state-of-the-art
clinical facilities spread across the globe. Since its start in 1998, Integrum AB has been
helping individuals with amputations get improved quality of life. Decades of scientific
research and development within the field of osseointegration has generated the OPRA TM
Implant System for bone-anchored prostheses. This unique approach, utilizing implants of
titanium alloy and scientifically well documented concept of osseointegration, offers
significant advantages for the patient compared to traditional socket prostheses. Among
these advantages are the ability to once again feel the ground beneath your feet, avoid the
pain and discomfort of a chiding socket, and to wear the prosthesis for a longer period every
day. The OPRA TM Implant System has been in use since the first treatment in 1990, and
today more than 500 patients are using an osseointegrated prosthesis replacing an arm, a
leg, or a digit. Integrum is also the only company in the world to have received a PMA (Pre-
market Approval) from the FDA, for its products used in the treatment of above-knee
amputations. We are based in Gothenburg, Sweden and in the US.
Integrum AB is listed on the Nasdaq First North in Sweden since May 15, 2017.