£60,000 - £70,000
Reporting to one of the Engineering Team Leaders, the Principal Mechanical 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. Your creativity, knowledge and experience will enable you to identify and to resolve complex engineering problems.
You will also be responsible for managing external engineering resources and for supporting and mentoring other members of the Engineering Team. You will also play a significant role in supporting the development and maintenance of departmental operating systems and processes.
- Directly supporting projects in the role of “Design Authority”, leading 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.
- Engaging and managing services from external contract design houses, contract manufacturing companies and specialist external suppliers.
- Understanding and managing stakeholder’s expectations, both internal and external
- 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 the 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 investigations to identify root causes of device issues, e.g. Fault Tree Analysis, Design of Experiments.
- Play a leading role in 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%.
- Significant experience in the design, manufacture and life-cycle management of medical device or combination products from concept to commercialisation (preferred, or, as a minimum, significant expertise from another relevant industry).
- Operates independently on engineering tasks, with minimal guidance required. Proactively identifies further tasks or activities required to resolve problems. Knows when to seek support.
- Experience of leading engineering teams (preferred) to achieve challenging project goals.
- 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.
- Knowledge of Solidworks 3D CAD (preferred).
- Ability to influence and educate. Confident in own judgement. Prepared to take difficult decisions and able to persuade others.
- Advanced skills in mentoring and coaching.
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.
Please apply ASAP for immediate consideration