Medical Device Experts
- Location:
- Hemel Hempstead jobs
,
Hertfordshire jobs
- Salary:
- £38,000 to £60,000 + Benefits
- Company:
- County Personnel Recruitment Ltd
- Job type:
- Permanent jobs
- Date posted:
- 05/11/2009 18:16
- Job id:
- 45871798
- Contact:
- Nick Flower
- Ref:
- Totaljobs
Our Client is looking for experts who have a broad range of experience in the development of medical devices in a number of areas:
1.Devices used with human soft tissue
The ideal candidate will have the experience in the following areas:
·Soft tissue surgical implants (other than orthopaedic, vascular or active implants)
·Long and short term surgical implants
·Implants that are made of plastics, metal, viscous gels, absorbable or non absorbable
·Neurological or central nervous system contact devices
With experience one of the following industry sectors:
- neurosurgery,
- reconstructive and general surgery,
- pulmonary/respiratory,
- trauma/emergency
- women's health/gynecology
- urology and renal
2.Medical Device Software
The ideal candidate will have the experience or ability in the following areas:
- System level – knowledge of the regulations and standards relating to programmable electronic systems, software lifecycle management and risk management
- Device level – Experience of working in software development, preferably on medical devices.Capable of reviewing technical documentation/design dossiers for active medical devices, including the software needed for its operation
- Quality Management Systems – Capable of site assessment of active device manufacturers including design controls and software development processes.
- Training and communication – ability to lead a group of software specialists chosen from Healthcare technology teams and communicate the requirements for software and programmable electronic systems to our reviewers and assessors.
3.Medical Device Telemetry and R&TTE directive
The ideal candidate will have the experience or ability in the following areas:
- Electronics engineer specialising in communications
- Knowledge of regulations and standards relating to radio communications
- Experience of active medical devices incorporating telemetry systems
The Job
Experts in a number of parts of the regulatory process:
- as a technical expert assessing manufacturers’ technical files and design dossiers;
- as a member of teams that audit device manufacturers’ quality systems;
- as a technical expert advising audit teams on aspects of the manufacturer’s design or production processes.
- Experts review design data (risk analysis, biocompatibility, clinical investigation data and post market surveillance information etc.), prepare recommendations for CE certification and participate in audit activities as a technical expert.
Qualifications and Experience
Candidates will be motivated to perform detailed investigation of complex technical and regulatory issues, enjoy learning new disciplines and discussing issues with applicants and have the presence to make and explain any difficult decisions. They will have contributed to one or more of the following medical device compliance aspects:
- device design, manufacture, testing and evaluation
- clinical trial or use of devices
