Senior Mechanical Engineer - Remediation - £40-55k - Cheshire, UK
As an experienced Engineer in the field of medical device and combination product development, you will be responsible for ensuring that projects, primarily injection device development projects, are delivered according to best practice. You will apply your engineering expertise, your knowledge of the relevant regulations, directives, guidelines and standards and your creativity to solve complex problems.
You will lead engineering reviews of projects in order ensure that all of the essential design requirements have been identified, implemented and verified and that the requirements of Design Controls have been met. Where gaps are identified, you will work with the SDT team and our partners to deliver the necessary steps required to close those gaps. As a subject matter expert you will also contribute to the continuous improvement of departmental procedures and ways of working.
- Conduct comprehensive design reviews of injection device development projects.
- o Perform engineering analyses of designs in order to identify any shortfalls in engineering quality, safety, robustness or reliability.
- o Ensure that Design Control documentation is in compliance with our clients Quality Management System.
- o Confirm that all new or existing risk controls identified during safety risk management activities have been identified, implemented and completed. .
- Where gaps are identified, determine and deliver the engineering remediation activities.
- o Actions will vary significantly between projects, from closing "documentation gaps" to identifying, evaluating and implementing design changes.
- o This will require working with teams from within the Steriles Device Team and, if required, external suppliers.
- Contribute to the continuous improvement of departmental practises:
- o Support development of Standard Operating Procedures, guidelines and templates.
- o Coaching and supporting team members.
- Will travel globally as required to support the projects, up to 25% of time out of the office. Travel might include visiting suppliers’ facilities or Teva manufacturing sites.
- Interfaces with numerous other business units, including legal, commercial, drug development, operations regulatory and procurement.
- In situations where activities are contracted out to third parties, will be responsible for interfacing with these external suppliers as well as assessing and approving their output.
- Reporting to the Head of Remediation, who reports to the Head of Steriles Device Team. The Steriles Device Technology is part of the Global R&D Innovation Technology business unit.
- Graduate in Engineering, Scientific or other Technical discipline.
- Experience in working with medical device or combination products development, in particular the application of Design Controls and medical device Risk Management to drug delivery devices, would be advantageous.
- Experience of medical device, combination/medicinal product regulatory requirements for global commercialisation.
- Technical knowledge and ability to understand and to resolve typical problems encountered with developing mechanical systems and manufacturing processes.
- Competent in the use of statistical methods, for example for the determination of design input requirements, verification and validation testing.
- Knowledge of 3D CAD (e.g. SolidWorks) would be advantageous.
- Pragmatic approach to problem solving and balancing conflicting requirements. Willing to take initiative.
- Good verbal and written communication.
- Cooperative and helpful attitude towards colleagues and customers. Aptitude for working in a team environment.
- Enjoys challenge. Adapts to change, coping with risk and uncertainty, while remaining positive. Willing to operate outside remit to meet deadlines when necessary.
- Mechanical Engineering
- Medical Devices
- Scientific Background