Job Description:
About the Role 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 in various departments. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients, and to be involved in the evaluation of cutting edge innovation and state of the art technologies. This is a Full time salaried, home-based role in the United States with some travel (15-25%). 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 interpersonal communication and project management skills are at the heart of this role as you work on a daily basis with medical device manufacturers as they plan and execute their conformity assessment projects. About You 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 demonstrated: Strong interpersonal and communication skills A track record in project or program management You’ll hold a Bachelor’s, 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: Orthopaedic and Dental (O&D) – Dental materials eg cements, fillers, adhesives, etc, Dental membranes (for guided bone regeneration), Viscosupplementation devices eg Hyalauronic Acid, Shoulder joint replacement, Sports Medicine devices eg bone anchors, Small joints eg ankle, elbow, toes. 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 – 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. Medicinal – devices which incorporate a medicinal substance, pharmaceutical processes and documentation, clinical trials, active pharmaceutical ingredients, medicinal chemistry, pharmaceutical law, ethics and administration, formulation, GMP, biopharmaceutical analysis, pharmacokinetics, pharmacology. You’ll also hold a Pharmaceutical Degree BSc, Master’s degree or PhD (or equivalent qualification). Microbiology – subject matter expert in the area of sterilization and microbiology for medical device reviews and third party quality audits. Requires hands-on experience sterilization validation, microbiology testing, packaging validation, and sterilization techniques such as gamma, e-beam, steam, ethylene oxide and aseptic fill. This position involves 50-60% travel. About BSI Do you believe the world deserves
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