Position name :balloon engineer sme
responsibilities:
1. leading the development of in‑house balloon capabilities at qmx (and extrusion capability if approved).
2. collaborating with quasar ireland (qrb) during the npd stage for balloon development.
3. work with site leader and engineering manager and function head to set up technical team that is in charge for balloon capabilities including training at quasar ireland (qrb) during npd stage, npi at qmx and future mp sustaining. Support in interviewing and choosing appropriate team members.
4. travel with critical team to qrb to develop balloons and get training.
5. travelling with selected team members to qrb for balloon development activities and technical training
6. developing and training the qmx team to build strong balloon technical knowledge and independent troubleshooting capability.
7. working with the pmo team to develop a full project plan and complete qualification within the agreed timeline.
8. acting as the primary technical point of contact for customers during project qualification.
9. ensuring projects are delivered on time, within budget, and to required quality standards.
10. work with assembly level line engineering problem solving on technical issues driven from component balloon level.
11. ensure project execution at npi stage is in full compliance with qms requirements, and customer expectations.
12. set up the regular maintenance system to make sure robust mass production.
13. support other npi projects as an npi engineer, once bandwidth allows, following the same npi execution principles as defined for the balloon project
14. any other task as assigned by site leader (manager)
qualification:
* + 3 years’ experience in processing, develop and produce balloon catheters.
* knowledge of iso 13485:2003, gmp, fda, qsr.
* understanding common machine shop practices, fixture design and assembly techniques of balloon catheters.
* related experience within international standards (iso 13485 / 9001), fda and european quality systems requirements (qsr, mdd), and risk management (iso 14971, dfmea and pfmea).
* well-developed written and verbal communication skills in english and spanish. Ability to write and comprehend instructions, short correspondence, and memos in both english and spanish. Interaction with customers is expected in this position.
* adept at presenting complex topics to customers and management.
* solid medical device engineering and manufacturing experience.