£45,000 - £60,000
Reporting to one of the Engineering Team Leaders, the Senior Mechanical Engineer will support the development of safe and effective products through the application of best practice engineering, Design Control and Safety Risk Management and knowledge of the relevant combination product regulations, directives, guidelines and standards.
You will exhibit creativity, knowledge and experience will enable you to identify and to resolve complex engineering problems. 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. You will also play contribute to the development and maintenance of departmental operating systems and processes.
- 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.
- 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.
- Some domestic and overseas travel may be required approximately 10%.
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.
Qualifications and Accreditations
- Graduate in Engineering, Scientific or other Technical discipline.
- Line Management, and or budgetary accountability
- Management of externally sourced Engineering services and associated budgets.