Neuro-Vascular Technical Product Specialist - Medical Devices - Europe
Salary: 45,000 - 65,000 Pounds or 55,000 - 80,000 EUR
Conditions: Full Time
Location: ANYWHERE UK / EUROPE.
About the Role:
As the Technical Specialist you will be involved in the review and evaluation of your client’s medical device technical documentation and your opinion will influence which products go to market. You’ll be working with a variety of medical device manufacturers globally, managing a portfolio of product types, with a commitment to delivering a diligent and timely service.
The fast paced nature of this rewarding role will eventually require you to work autonomously with manufacturers as they execute their 'go to market’ plans.
The role requires the Technical Specialist to be efficient and effective in; comprehending technical information, targeted questioning, forming opinions and offering recommendations. The role requires the Technical Specialist to provide a critical, but common sense, evaluation of the information provided by the manufacturer to demonstrate conformity with applicable regulations or standards.
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.
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, 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, guidewire, introducers, and closure devices.
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.
Requirement: Currently recruiting Medical Device Technical Experts for the following device categories:
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.
Skills and Expertise::
Candidates will have medical device experience within an industrial, academic or clinical background in Neuro-Vascular Expertise.
Neurovascular Experience: Embolic coils, neurovascular stents and related accessories.
Would expect them to have basic experience with other cardiovascular devices: Balloon catheters, guidewire, introducers, closure devices, etc. that are typically used in the conjunction with the above devices.
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.
You’ll also hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
Job Titles: Scheme Manager - Technical Specialist - Medical Device Expert - R&D Manager - Certification Manager - Project Manager - Design Control Manager - Technical Manager - Project Manager - Product Specialist - Product Development Manager.
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- Design Development
- Medical Devices
- Research Development
- Technical Specialists
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