Senior Device Engineer - North West (Relocation Support Provided)
Job Title: Senior Device Engineer
Location: North West, UK (Relocation Support Provided)
Industry: Medical Devices
Type: Permanent, Full Time
Reporting to the Engineering Team Leader, the Senior Device Engineer will ensure that the products for which you are responsible are safe and effective through the application of best practice engineering, Design Control and Safety Risk Management and your knowledge of the relevant combination product regulations, directives, guidelines and standards. You will also use your experience of production processes and manufacturing technologies, such as plastic injection molding processes, to prepare those designs for transfer into production. Your creativity, knowledge and experience will enable you to identify and to resolve complex engineering problems.
- Supporting the engineering design and development of drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle management.
- Ensure that products for which you are responsible are:
- Engineered to be reliable and robust, through the application of appropriate design, analysis and testing.
- Verified by the provision of suitable objective evidence.
- Documented in compliance with CPD’s Quality Management System.
- Lead or support Safety Risk Management activities
- Including Hazards identification, analyzing and evaluating risk, conducting design and process FMEA.
- Lead or support technical design reviews to assess robustness and safety and documentation quality compliance.
- Lead or support investigations to identify root causes of device issues, e.g. Fault Tree Analysis, Design of Experiments.
- Contribute to the continuous improvement of departmental processes, including supporting development of Standard Operating Procedures, guidelines and templates, introduction of new software tools etc.
Knowledge, Skills and Abilities
- Experience in the design, manufacture and life-cycle management of medical device or combination products from concept to commercialisation (preferred, or, as a minimum, expertise from another relevant industry).
- Operates with a high degree of independence on engineering tasks, with only limited support or guidance required. Uses initiative to identify further tasks or activities required. Knows when to seek support.
- Training in Design Controls, medical device risk management and European Medical Device Directive/Regulations (preferred).
- Familiarity with statistical methods, for example for the determination of design input requirements, verification and validation testing.
- Excellent 3D spatial awareness and visualisation of concepts, mechanisms and assemblies
- Knowledge of Solidworks 3D CAD (preferred).
- Ability to influence and educate. Confident in own judgement.
- Analytical engineering assessment of mechanisms and systems, building understanding from a "first principles" basis.
- Can effectively cope with change, coping with risk and uncertainty while comfortably adapting to changing conditions.
- Good verbal and written communication including high quality engineering documentation.
Qualifications and Accreditations
Graduate in Engineering, Scientific or other Technical discipline.
Line Management, and or budgetary accountability
Management of externally sourced Engineering services.
Key words: TECHNOLOGIES / MEDICAL / NPD / NEW PRODUCT / PRODUCT DEVELOPMENT / R&D / LEAD / TEAM LEAD / PROJECT LEAD / PROJECT MANAGER / ENGINEER / ENGINEERING / ELECTRICAL ENGINEERING / ELECTRICAL / SCADA / SYSTEMS ENGINEERING / CONTROL SYSTEMS / INSTRUMENTATION / EQUIPMENT / LABORATORY / EQUIPMENT / DRUG DELIVERY / INJECTABLES / STERILES / STERILITY / COMBINATION DEVICES / MEDICAL DEVICES / PHARMA / PHARMACEUTICAL / GMP / ENGINEERING / CONTRACT MANUFACTURING / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / R&D / PRODUCT DEVELOPMENT / DESIGN / ENGINEER / SCIENTIST / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / NORTH WALES / UK / UNITED KINGDOM / EUROPE / ENGLAND / RELOCATE / GSK / GLAXO / BESPAK / ASTRA ZENECA / ASTRAZENECA / MEDTRADE / JOHNSON JOHNSON / NOVARTIS / QAIGEN / PFIZER / SANOFI / PRODUCT DEVELOPMENT / ENGINEER / ENGINEERING / CLINICAL / PACKAGING / BIOMEDICAL / MEDICAL / HEALTHCARE / REGULATORY AFFAIRS / QA / QUALITY ASSURANCE / PHARMASERVE / INVIBIO / VICTREX / CONVATEC / AMS / BIOMEDICAL ENGINEERING / PHARMA / PHARMACEUTICALS / GMP / DRUGS / CLINICAL / MECICAL DEVICES / MEDICAL TECHNOLOGY / MEDICAL DEVICE
- Design Development
- Medical Devices
- Product Development
- Research Development
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