BSI Group Medical Device Technical Specialist in Italy
Do you have experience within the medical field? Have you worked with Medical Devices previously? Would you like to work with cutting edge innovation and state of the art technologies?
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 is a home based role which could be carried out remotely in Italy.
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 | Ophthalmic | Woundcare | Soft Tissue | Vascular | Contraceptive | Active | AIMD | O&D | Orthopaedic & Dental | Orthopaedic | Dental |Quality Management | Research | Design | Development | R&D | Research and Development | Engineering
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. 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
A track record in project or programme management
You’ll hold a BSc, Master’s degree or PhD (or equivalent qualification) in a discipline relevant to medical device manufacture and use.
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:
Ophthalmic - contact lenses, intraocular lenses, other ophthalmic implants (capsular tension rings, eyelid, stents/shunts etc), viscoelastic, ophthalmic solutions, surgical instruments and tools indicted for use in the eye.
Orthopaedic and Dental (O&D) - Orthopaedic implants - specifically joint replacement implants (hip / knee) or spinal devices; Dental implants - titanium screw implants, Guided Tissue Regeneration implants, or dental membranes; General orthopaedic & non-active devices.
Woundcare - films, gels, textile, hydrogels, creams, hydrocolloids, foams, silicone, super absorbers, haemostats, extra cellular matrices and composite dressings.
Active - 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.
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.
Contraceptive - contraceptive devices with and without medicated coating, latex dipping and or plastics based technology and its manufacture, coatings technologycontraceptive, female healthcare products.
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 - 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.
What we offer:
We offer a highly competitive starting salary of circa €60,000 plus 10% 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.
Externally Advertised Salary: Circa €60,000 10% bonus
External Company Name: British Standards Institution, The
External Company URL: www.bsigroup.com