Senior Design Assurance Manager
Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. 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 English speaking 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):
Senior Design Assurance Manager
- You provide design assurance support and oversight for product development activities throughout product lifecycle.
- You create, review and/or execute IQ, OQ, PQ and test method development.
- You ensure product development follows company procedures and design control requirements.
- You review and approve design verification and design validation test protocols and reports.
- You support protocol sample size calculations and data analysis with use of acceptable use of statistical methods/techniques.
- You drive robust design reviews within R&D teams.
- You ensure compilation and maintenance of product Design History Files.
- You document traceability of requirements through design output and to design verification and/or design validation.
- You lead the risk management process for pre-market and post-market assessments of assigned products.
- Bachelor or Master’s degree in Engineering, Life Sciences or another related field.
- 10+ years’ experience working in a Quality or Engineering capacity with Class III medical devices. Experience with catheters and active devices preferable.
- Experience with all phases of the product development process including clinical investigation.
- Experience in creating and maintaining Risk Management Files.
- Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards.
- In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
- Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
- Excellent organisational and communication (oral and written) skills.
- Ability to work on teams as well as individually.
- Fluent in English (oral and written).
- A challenging and diversified 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.
- An attractive compensation package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter via http://www.pahrtners.be/job/senior-design-assurance-manager/ or to firstname.lastname@example.org.
Your application and related information will remain strictly confidential.
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