AIMD DEVICES EXPERT/MANAGER - Medical DEVICES - US
Business: Medical Units & Healthcare - Lively Implantables - Lively Units - EN60601
Job Title: Scheme Supervisor - Technical Specialist - Medical System Professional - Certification Supervisor - Challenge Supervisor - Design Management Supervisor
Location: House Based mostly, US
Wage: one hundred-130k US
Coaching: Sure (Full)
Organisation: a Notified Physique for the Medical Gadget Business.
In the present day you're working from house reviewing fatigue check knowledge on a brand new drug eluting stent design of considered one of your clients. Tomorrow you audit the manufacturing amenities of a giant producer of PTCA catheters in Germany. Subsequent week you current at a medical system regulatory convention in Sweden. As A Technical Lead, Scheme supervisor, Product professional and part of certainly one of our international know-how groups, you recognize the dynamic of working in a mixture of regulatory affairs, high quality auditing and medical know-how improvements. You take pleasure in a world working setting in a rising group of medical system specialists, working with small begin-up and enormous multi-nationwide shoppers, a little bit of travelling and reviewing the newest applied sciences.
Requirement: Presently recruiting Medical Gadget Technical Specialists for the next system classes:
- Implantable units within the orthopaedic, dental, ophthalmic, IVD, Dialysis, Lively units, smooth tissue implants, wound care and cardiovascular fields.
- Sterility Aseptic Sterile Manufacturing
- Electro-medical units for diagnostic or therapeutic functions.
Perform of the place:
- As a technical professional assessing the producer's technical information and design dossiers;
- As a member of a staff auditing a tool producer's high quality system;
- As a regulatory professional and scheme supervisor, managing a portfolio of shoppers with respect to providers supplies to them.
Staff members have general shopper administration obligations and will probably be competent to assessment crucial design knowledge (together with danger evaluation, labeling, medical investigation knowledge and publish market surveillance info) and to organize suggestions for CE certification.
Qualifications and Expertise:
Candidates may have medical gadget expertise inside an industrial, educational or medical background.
Their qualifications will mirror a radical understanding of the technological issues and manufacturing processes related to the sector by which they've labored.
Profitable candidates can be motivated to carry out detailed investigation of complicated technical points, have a want to study new disciplines, are robust communicators, and have robust analytical and organizational expertise, and have the presence to make and clarify troublesome selections if crucial.
60601 / 60602 / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL / ELECTROMECHANICAL / ELECTRO MECHANICAL / QA / QUALITY ASSURANCE / ISO13485 / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / CLASS 1 / CLASS 2 / CLASS three / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH /DEVELOPMENT / MEDICAL DEVICES / STERILES / SURGICAL / INFUSION / BOSTON SCIENTIFIC / ORTHOPEADIC / DENTAL / OPHTHALMIC / SOFT TISSUE / VASCULAR/ CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / RADITATION/ BENELU",FRANKFURT, SWITZERLAND, FRANCE/ENGLAND / US / USA / EUROPE / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / KARL STORZ / TUV / SGS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / RELOCATE / SWEDEN / AUSTRIA /BELGIUM / RANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / PARIS / FRANCE / California, North East, Minneapolis, Utah, Florida, Texas, New York, Virginia, Pennsylvania, Ohio, Carolina, Toronto, USA / Coronary heart valves, transcatheter, aortic valves, aortic, grafts, Coronary, peripheral stents, Cerebral, Coils, Ablation, catheters / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / DRUG DELIVERY / CAREFUSION /SIEMENS / TUV / SGS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / PARISOLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / GE HEALTHCARE / California, North East, Minneapolis, Utah, Florida, Texas, New York, Carolina, Virginia, Pennsylvania, Ohio, Carolina, Toronto, San Francisco, Los Angeles, Utah, Nevada, Idaho, Montana, Nebraska, Dakota, Las Vegas, Oregan, Washington, Chicago, Iowa, Indiana, Michigan, New York, Toronto, Pennsylvania, Kentucky, New Jersey, Connecticut, Missisippi, Houstan, Texas, Alabama, Louisianan, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado
- Design Improvement
- Medical Units
- Product Improvement
- Analysis Improvement
- CE marking