QSTAR MEDICAL SA
- Référence : 317
- Date : 11-07-2012
- Ville : Paris
- Dept : 75
We are seeking an R&D Engineer to play a key role in the design and manufacture of our ‘next generation’ vascular access implant devices made in part with the innovative STAR® Biomaterial. qSTAR is the second spinout of Healionics Corporation USA www.healionics.com – the producers of STAR Biomaterial. As a startup, qSTAR is establishing its first facility in the Paris – Isle de France region.
Poste proposé : Ingénieurs seniors
Descriptif du poste
SEEKING: Senior Engineer, Medical Device Research & Development - Experienced in medical device design and manufacturing? - Fascinated by new biomaterial technologies to bring unique medical implants to market? - Interested in pioneering better ways to design and manufacture vascular access medical implants? - Enjoy start-up company environments where your contribution is highly recognized and valued? WHAT WE NEED: - Lead the research and development of a new medical device implant system. - Collaborate with partners, subcontractors, and suppliers teams. - Research, recommend and procure materials and equipment. - Design & develop fixtures for component and product concept testing. - Develop protocols and generate documentation and reports in accordance with ISO13485, FDA QSR, and internal Quality and Document Management Systems. - Create prototypes and establish pilot processes for new products. - Plan and oversee new engineer and technician activities delegated as growth demands. WHAT YOU NEED TO HAVE: - Degree in Mechanical Engineering and/or equivalent relevant experience. PhD a plus. - 5+ years experience in medical device prototyping and production. - Familiar with FDA, GMP, QSR and ISO 13485 requirements. - Experience with Design Control Methodologies and Equipment IQ, OQ, PQ. - Experience working with and maintaining controlled environments (ISO 7 cleanroom). - Experience with medical materials for long-term implants a plus. - Experience with vascular access device design and manufacturing a plus. - Experience with End Stage Renal Disease / Kidney Dialysis devices a plus. - Proficiency with 3D solid modeling software. - Knowledge of biomaterials, plastics, elastomers, and solvents a plus. - Plastics Processing (molding, extrusion) and Packaging (F/F/S) experience a plus. - Excellent written and verbal communications skills in both English and French. - Ability to work well both independently and within a diverse team in Europe and USA. - Ability to manage multiple projects simultaneously. - Ability to travel internationally for up to two week periods.
Experienced in medical device design and manufacturing - Fascinated by new biomaterial technologies - Enjoy start-up company environments
Degree in Mechanical Engineering and/or equivalent relevant experience. PhD a plus
- QSTAR MEDICAL SA
- Email : email@example.com
- 40, Rue des Blancs Manteaux 75004 Paris
- Téléphone : 33(0)1-48-04-50-35