AIMD DEVICES EXPERT/MANAGER - MEDICAL DEVICES - US
Industry: Medical Devices & Healthcare - Active Implantables - Active Devices - EN60601
Job Title: Scheme Manager - Technical Specialist - Medical Device Expert - Certification Manager - Project Manager - Design Control Manager
Location: Home Based, US
Salary: 100-130k US
Training: Yes (Full)
Organisation: a Notified Body for the Medical Device Industry.
Today you are working from home reviewing fatigue test data on a new drug eluting stent design of one of your customers. Tomorrow you audit the manufacturing facilities of a large manufacturer of PTCA catheters in Germany. Next week you present at a medical device regulatory conference in Sweden. As A Technical Lead, Scheme manager, Product expert and part of one of our global technology teams, you appreciate the dynamic of working in a mix of regulatory affairs, quality auditing and medical technology innovations. You enjoy an international working environment in a growing team of medical device experts, working with small start-up and large multi-national clients, a bit of travelling and reviewing the latest technologies.
Requirement: Currently recruiting Medical Device Technical Experts for the following device categories:
- Implantable devices in the orthopaedic, dental, ophthalmic, IVD, Dialysis, Active devices, soft tissue implants, wound care and cardiovascular fields.
- Sterility Aseptic Sterile Manufacturing
- Electro-medical devices for diagnostic or therapeutic purposes.
Function of the position:
- As a technical expert assessing the manufacturer's technical files and design dossiers;
- As a member of a team auditing a device manufacturer's quality system;
- As a regulatory expert and scheme manager, managing a portfolio of clients with respect to services provides to them.
Team members have overall client management responsibilities and will be competent to review critical design data (including risk analysis, labeling, clinical investigation data and post market surveillance information) and to prepare recommendations for CE certification.
Qualifications and Experience:
Candidates will have medical device experience within an industrial, academic or clinical background.
Their qualifications will reflect a thorough understanding of the technological considerations and manufacturing processes relevant to the field in which they have worked.
Successful candidates will be motivated to perform detailed investigation of complex technical issues, have a desire to learn new disciplines, are strong communicators, and have strong analytical and organizational skills, and have the presence to make and explain difficult decisions if necessary.
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 3 / 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 / 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 Development
- Medical Devices
- Product Development
- Research Development
- CE marking
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