VASCULAR TECHNICAL PRODUCT SPECIALIST - MEDICAL DEVICES - CHINA

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VASCULAR TECHNICAL PRODUCT SPECIALIST – MEDICAL DEVICES – CHINA

Industry: Medical Devices & Healthcare

Job Title: Scheme Manager – Technical Specialist – Medical Device Expert – Certification Manager – Project Manager – Design Control Manager

Function: Vascular Devices.

Location: CHINA

Salary: Negotiable

Type: Permanent

Organisation: a Notified Body for the Medical Device Industry.

Typical:

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 Vascular Devices categories, including:

Stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories) and have basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.

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:

To be successful in this role you will need to apply the significant knowledge and extensive ‘hands on’ experience that you have gained in research, design and development of medical devices, including the application of the principles of design control, risk management and performance or clinical evaluation. The right candidate will have demonstrated strong inter-personal and communication skills, as well as a track record in project or programme management. Good written and spoken English language skills are essential.

The role requires you to have extensive experience in the design, development and manufacturing of at least a few of the following Vascular Devices including, stents and stent delivery systems, percutaneous heart valves, devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories) and have basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.

You’ll also hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.

60601 / 60602 / ACTIVE DEVICES / ELECTRICAL / ELECTRONICS / ELECTRO-MECHANICAL/ QA / QUALITY ASSURANCE / ISO13485/ 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 / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCUALR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND/ BENELUX”,”FRANKFURT”,”POLAND, BELGIUM, SWITZERLAND, FRANCE, GERMAN / 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 / FRANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / PARIS / FRANCE / USA / Heart valves, transcatheter, aortic valves, abdominal aortic aneurysms, grafts, Coronary, peripheral stents,Cerebral,Coils,Ablation,catheters / ASIA PACIFIC / CHINA,BEIJING,SHANGHAI,SHANDONG,HENAN,XIAN,SHAANXI,HUBEI,WUHAN,JIANGSU,NANJING,ANHUI,FUJIAN,ZHEJIANG,TAIWAN,GUANGDONG,HUBEI,HONG KONG,NANJING,ANHUI,WUHAN,HANGZHOU,CHONGQING,CHENGDU,CHINESE ,Shanghai, Shenzhen, Nanjing, Jiangsu, Anhui, HANGZHOU, ZHEJIANG, BEIJING, SHANDONG, HENAN, WUHAN, CHINA, NAGOYA, TOKYO, JAPAN, CHIBA, SHIZUOKA, NAGANO, FUKUSHIMA, KANAZAWA, TOTTORI, OSAKA, TSU, HIROSHIMA, NAGASAKI, KUMAMOTO, AKITA, SENDAI, MATSUYAMA, SINGAPORE, NAGOYA, TOKYO, JAPAN, CHIBA, SHIZUOKA, NAGANO, FUKUSHIMA, KANAZAWA, TOTTORI, OSAKA, TSU, HIROSHIMA, NAGASAKI, KUMAMOTO, AKITA, SENDAI, MATSUYAMA / MAKASSAR / MALUKU / VIETNAM