Key words: Agile, leadership, medical technology, regulatory requirements, stakeholder analysis, stakeholder management, risk management, reporting, communication
Holland Innovative – Twente team
The Twente team of Holland Innovative is specialised in Medical Devices and High Tech markets. The team’s goal is to excel in launching new and reliable innovations that contribute to the quality of life. Therefore we strengthen the project teams of customers with Project Management and Design for Six Sigma methodologies. We believe that sharing our knowledge is essential to reach our goal. Therefore we give courses within our Academy and we create open innovation networks like the Living Lab. Currently the Twente team consists of 6 people –in total Holland Innovative consists of about 45 people at 2 locations- but in order to broaden or knowledge and to full-fill more interesting customer requests; we need a new team member in Enschede!
Our customers develop innovative high-tech (medical) devices. As Project Manager you will help them with what they need to make products which are relevant, reach the market and are reliable.
Focus of the job can be in the area of ‘classic’ project management; leading a multidisciplinary team of mechanical, software and hardware engineers in order to let them deliver an optimal device that meets the budget, timing, quality and above all, client satisfaction.
Depending on the organization of the customer and your preferences, this may be combined with a more quality & regulatory focus. Examples of activities are setting up the technical file, completing a -safety- risk management, arranging validation activities or even setting-up the complete Quality Management System for the business.
In all cases you will bring structure, show leadership and take initiative to make it work!
As project manager with a focus on MedTech you will work on medical devices, but we offer and expect the flexibility to work on other high-tech developments in other fields as well. It is our experience that this combination of projects gives you the opportunity to learn & to develop yourself in a broader way.
Within the HI Twente team we maintain our own project portfolio. This will give you the opportunity to arrange projects within your own area of interest.
- BSc or MSc degree in a technical discipline (for example Mechanical engineering, Physics, Electrical engineering, Technical medicine or Software development).
- Minimal 5 years of relevant working experience in product development, medical product development is a plus.
- Proven track record in leading teams in a role as project manager or team leader, IPMA certification is a plus.
- Experienced in the use of regulatory requirements and standards. Demonstrable experience in medical regulation like MDD, ISO 14971 and/or IEC 60601 is a plus.
- Experienced in the use of Quality Management Systems. Demonstrable experience in ISO13485 is a plus.
Important personal qualities are: ability to take leadership, feel responsible and excellent communication skills. A passion for innovation and being curious, with the ability to keep focus.
What we offer
Holland Innovative offers you a contract with excellent primary and secondary employment conditions, including 28 personal leave days plus the option to buy more personal leave days. We have a dynamic environment with a broad training program in for example: Design for Six Sigma Black Belt, statistics for medical devices or reliability engineering. We offer the possibility to gain experience within various interesting companies. The team in Enschede is open minded, willing to learn & inspire and interested in each other’s work and private lives. Our frequent team drinks and dinners create the space to really be a team!
Send your motivation and resume to Eefke van Daal (firstname.lastname@example.org). For more information on the content of the job, please contact Lisette van Steinvoren (Lisette.van.Steinvoren@holland-innovative.nl or 06-10352755).