Senior Manager, System Verificaton and Design Validation

Senior Manager, System Verificaton and Design Validation

Do you want to make a difference by developing key lifesaving medical device products? Are you an expert to lead verification/validation (V&V) testing for product development projects? Are you an energetic and organized person who looks for new challenges? Do you want to work for a truly global business who refuse to compromise when it comes to caring for people? If your answer is yes, you may be the candidate we are looking for!

HemoCue R&D is looking for an experienced medical device manager to lead our system verification testing and design validation (analytical and clinical testing) team. Your main task will be to manage and drive the testing phases of product development and sustaining engineering project(s), collaborate with CRO and external partners, coordinate in-house lab activities, and actively drive the team strategy.

Responsibilities
Your responsibilities include managing a team of 5-10 people composed of engineers, specialists and consultants. This will involve individual development, competence mapping and setting the team strategy.

You are responsible for the testing phase of different smaller and larger project and expected to plan and maintain the content, time, and budget for your projects and run daily management/visual management processes under the Danaher Business System. Depending of the type of project you will manage a team of engineers and scientists and interact with cross-functional resources from QA/RA, Marketing, Operations, Sales, Finance, in addition to R&D. Additionally, you will work together with external partners and CRO to perform Clinical Testing of our point of care diagnostics.

Another part of your task includes assuring that the lab is in a well-controlled state and you act as EHS (Environment, Health and Safety) responsible for the R&D department.

You will report to the Senior Director R&D and will be placed in Ängelholm, Sweden

Qualifications
We are looking for a person with the following experience and qualification:
  • MSc or equivalent in a suitable field of engineering or science
  • Experience from Medical Devices or Diagnostics product development
  • Experience from working in a Lab environment
  • Experience from running clinical Testing and/or collaboration with CRO
  • Project Management
  • People Management
  • Experience from regulatory standards, FDA, QSR and design control
You have excellent English in speech and writing, Swedish is an advantage.

On a personal level, you expect to be a strong leader who stands up for your team. In difficult situations, you stay calm and work methodically towards a solution with your team. You have excellent communications skills and enjoy working in a company that is driven by continuous improvement, both in term of equipment and processes. We place great emphasis on personal qualities for this role.

We offer you
A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development.

We are looking forward to receiving your application no later than December 9.

For further information, please contact Senior Director R&D, Magnus Tunklev, +46 431 48 14 13

Union contacts: Mikael Godolakis, Unionen, +46 431 48 14 66 or Elin Söderlind, Akademikerföreningen, +46 431 48 12 62.
Mer info
Område Ängelholm
Yrkesroll Organisation & ledning, Chefsbefattningar, Data & IT
Typ av anställning Heltid, Tillsvidareanställd
Hemsida https://www.hemocue.se/
Sista ansökningsdag 9 dec 2019 (3 dagar kvar)

Om arbetsgivaren

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.