Job Title: Medical Device Technical Specialist (M/F/D)
Firma : BSI Group
Have you worked with Medical Devices previously within a research, design and development setting? Would you like to work with cutting edge innovation and state of the art technologies in a home based role?
Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Technical Specialists. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.
This role offers real diversity and variety, building, controlling and managing a portfolio of Medical Device CE marking schemes focused around your area of expertise. In addition to reviewing and evaluating medical device technical documentation you could also be undertaking Medical Device QMS assessments or advising and mentoring colleagues in your areas of competence. Strong inter-personal communication and project management skills are at the heart of this role as you work on a daily basis with manufacturers as they plan and execute their conformity assessment projects.
Medical Devices | Technical Specialist | Woundcare | Quality Management | Research | product specialist | product manager | Design | Development | R&D | Research and Development | Engineer | Medical | Ophthalmic | Woundcare | Soft Tissue | Vascular | Contraceptive | Active | AIMD | O&D | Orthopaedic & Dental | Orthopaedic | Dental | Dialysis | Micro | Microbiology
Do you believe the world deserves excellence?
BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe and has been doing so since 1901. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company’s desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.
To be successful in this role you''ll 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 demonstrate -
- Strong inter-personal and communication skills
- 4+ years working in design, developement and research of a specific Medical Device
- You’ll hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.e.
The role requires you to have extensive experience in the design, development and manufacturing of Medical Devices which includes one or more of the following technologies:
- Orthopaedic and Dental- Dental membranes (for guided bone regeneration), Viscosupplementation devices e.g. Hyalauronic Acid and Absorbale Sports Medicine devices
- Woundcare - films, gels, textile, hydrogels, creams, hydrocolloids, foams, silicone, super absorbers, haemostats, extra cellular matrices and composite dressings.
- Soft Tissue - breast implants, dural implants, hernia meshes and plugs, prolapse meshes, tissue re-inforcement mesh devices, adhesion barriers, muscular implants, dermal fillers, sutures, surgical sealants, fixation anchors, staple line reinforcements, and scaffolds for tissue regeneration or repair.
- Dialysis - extensive experience in the design, development and manufacturing of blood treatment devices which includes one or more of the following technologies: dialysis, hemofiltration, apheresis, blood oxygenation, CO2 removal or dry and liquid concentrates for dialysis, chemical cleaning devices/disinfectants, production of purified water or devices for infusion, transfusion or storage of blood products.
- Active Devices - experience in electro-medical device technical development or testing and an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971.
- Active Implantable (AIMD) - Neuro stimulators, Pace makers, Implantable cardioverter-defibrillator (ICD), Stimulation leads, Infusion pumps, Ventricular assist devices (VAD, LVAD), Artificial hearts, Brachytherapy seeds and delivery systems, Cochlear implants , Implantable sensors, Medical Micro Electro Mechanical Systems (MEMS).
- Vascular - aortic aneurysms ablation and electrophysiology catheters, neurovascular experience (embolic coils, neurovascular stents and related accessories)
- IVD- A solid foundation of experience in the design, development, manufacture or testing (use) of In Vitro Diagnostics (IVDs). This may have been gained either for a manufacturer of IVD devices, or in a testing/pathology lab environment.
- Microbiology- A microbiologist with solid experience working with sterile medical devices.
What we offer:
We offer a highly competitive starting salary plus bonus. BSI also offers employees a wide range of flexible benefits that you can tailor to suit your life-style.
We pride ourselves on setting the industry benchmark and invest significantly in our teams to ensure that our people have the best possible opportunity to deliver an excellent service and progress their careers. As the successful candidate, you will embark on a comprehensive induction into the role and will be supported in a continuous professional development programme.