A Day In The Life Of A Senior Mechanical Engineer
Reporting to the Senior Engineering Project Leader, you, as Senior Device Engineer, will ensure that the products for which you are responsible are safe and effective through the application of best practice engineering, the application of Design Controls 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 moulding, to prepare those designs for transfer into production. Your creativity, knowledge and experience will enable you to identify and resolve complex engineering problems. You will also contribute to the development and maintenance of departmental operating systems and processes and have the opportunity to influence departmental best practice.
Key Responsibilities:
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 (by conducting design Failure Modes and Effects Analyses (FMEAs) and supporting the Manufacturing, Science & Technology (MS&T) function to conduct process risk assessments).
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 using established techniques 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 (e.g. to visit suppliers’ facilities, Teva manufacturing sites), approximately 10%.
Who We Are Looking For
Do you have?
Graduate in Engineering, Scientific or other Technical discipline
Experience in the design, manufacture and life-cycle management of medical device or combination products from concept to commercialisation
Or alternatively, experience from another relevant industry
An understanding of Design Controls, medical device Safety Risk Management and European Medical Device Directive/Regulations would be preferred.
Familiarity with statistical methods, for example for the determination of design input requirements, verification and validation testing, especially the derivation of test sample sizes proportionate to risk.
Excellent 3D spatial awareness and visualisation of concepts, mechanisms and assemblies
Knowledge of Solidworks 3D CAD would be desirable.
An analytical engineering assessment of mechanisms and systems, building understanding from a “first principles” basis.
Are you?
Someone who operates with a high degree of autonomy/independence on engineering tasks but understands when there’s a need to seek support from others within the team
Able to influence and educate with confidence in your own judgement
An individual that can effectively cope with change, managing risk and uncertainty whilst adapting to shifting conditions.
Capable of communicating both verbally and in writing across colleagues and stakeholders both internally and externally
Bringing mentoring and coaching skills which can help guide others across the department
If so – we would value hearing from you!
