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Senior R&D Project Leader

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Medical Device - Awans (Liège)

Founded in 2009, CryoTherapeutics is an early stage European innovative company that is now establishing its operations in Liège (Awans). The company is in the process of developing a novel catheter system to treat atherosclerotic plaque that causes heart attacks by delivering cryoenergy to the coronary arteries. For additional information about the company, please visit http://www.cryotherapeutics.com/

CryoTherapeutics aims to develop and market the novel cryoenergy therapy initially for patients who have suffered a heart attack, and in the longer term also for patients identified as being at future risk of heart attack. CryoTherapeutics recently raised 7M€ in its latest round of financing and will use these funds to continue development of this technology with the aim of starting clinical studies later this year.

In order to support the expansion of the team in Awans, we are looking for a (m/f):

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Senior R&D Project Leader

Responsibilities:

As a Senior R&D Project Leader, the candidate will lead strategic R&D projects, including software and hardware components and equipment. Reporting to the CTO, the candidate will lead innovation throughout the company.

The positions’s main responsibilities are:

  • Lead strategic R&D projects from concept to commercialization including specifications, design, prototype, industrialisation, manufacturing, and commercial release of software driven electromechanical systems.
  • Ensure resources, processes, procedures and controls are adapted to the projects needs.
  • Lead internal and external project teams with respect to timelines, budgets, quality, safety and business requirements.
  • Analyse the market, select, lead and manage supppliers, vendors, contractors and external partners in order to meet the innovation goals.
  • Understand medical safety requirements, FMEA and risk analysis. Prepare validation plans in line with company documentation, CE and FDA requirements and industry standards.
  • Lead compliance to the Quality Management Systems (ISO 13485 environment).
  • Be a key person of contact for KOL, scientific experts and governmental authorities.
  • Develop appropriate test methods and write protocols and related reports,
  • Report results and work evolution on a regular basis to the top management.
Profile:
  • Engineering Master’s degree in Electronics, electromechanical or related fields.
  • At least 7 years experience in R&D positions within small and large medical devices companies.
  • Expertise in hard- and software technologies and, ideally, also in catheter engineering, including equipment and software validations
  • Excellent project management methodologies and tools.
  • Strong leadership and communication skills together with hands-on and pragmatic mind-set.
  • Proven record of dealing with vendors for electromechanical and software based systems for medical devices,
  • Very good organizational, analytical and problem solving skills.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Excellent oral and written communication skills in English. Any other language is a plus.
  • Prone to travel up to 20% of your work time.
  • Despite joining at senior level, be a hands-on person and can lead and manage the team as well as perform some of the work at task.
Offer:
  • A challenging position with a high potential innovative and young medical device company.
  • To work in a human-sized, collaborative and respectful environment
  • Work within a dynamic and experienced team that brings the best out of motivated potentials.
  • An attractive compensation package in line with the position’s responsibilities and your experience.
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