Offre d'emploi : Catheter Engineer
Miracor Medical is a class IIb/III medical device company active in interventional cardiology and specialized in improving clinical outcome of patients with impaired cardiac function.. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).
The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.
Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com.
Miracor Medical offers a culturally diverse working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.
To support the development of the company, we are looking for a (m/f):
As a Catheter Engineer, you lead and take care of product development efforts per Miracor Medical’s Design Control Processes. Reporting to the Senior Director R&D, you play a key role in the R&D/innovation activities. Your main responsibilities are:
- You determine design inputs for novel catheters based on your analysis of customer complaints and returns, and inputs of users, internal stakeholders and quality standards.
- You conduct product development efforts following the company procedures and design control requirements.
- You identify and manage contract suppliers capable of designing and developing catheters.
- You manage scale up and process improvement of existing product line(s).
- You work with Design Assurance to establish a project plan for device development.
- You generate technical documentation (i.e. Design History File, Risk Management Documents, Product/Process Validation Protocols/Reports) and write Trace Matrices to establish traceability of requirements from design inputs through design outputs.
- You organize regular cross-functional team meeting to ensure project(s) adhere to plan.
- You contribute to the Company Quality Objectives (QMS-POL 0003).
- Mechanical or Biomedical Engineering Master’s degree.
- 3 years of experience in catheter development, preferably balloon catheters.
- Experienced with SolidWorks, AutoCAD or similar.
- Strong innovation and communication skills together with hands-on and pragmatic mind-set.
- Very good organizational, analytical and problem-solving skills.
- Ability to work independently and to properly interact with supplier companies, company personnel and end users.
- Excellent oral and written communication skills in English. Any other language is a plus.
- You are prone to travel up to 20% of your work time.
- A challenging technical position within a high-potential innovative medical device company.
- To work in a human size, dynamic, respectful and professional environment.
- International exposure, with learning and development opportunities.
- Varied contacts through external collaborations and partnerships.
- An attractive compensation package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter http://www.pahrtners.be/job/catheter-engineer-2/ or to firstname.lastname@example.org.Your application and related information will remain strictly confidential.