Senior Principal Mechanical Engineer (Permanent)
Location: United Kingdom
Type: Permanent, Full Time
As a subject matter expert in the field of design and development of medical device or combination products, you will be responsible for ensuring that projects and programs, primarily injection device development projects, are delivered according to best engineering practice. You will have state-of-the-art knowledge of the regulations, directives, guidelines and standards, engineering practises, tools and technologies relevant to the development of medical devices and combination products. Your creativity, knowledge and experience will enable you to identify and to resolve complex engineering problems and to anticipate, and hence to avoid, problems before they develop.
As a specialist in the field of medical device and combination product development, 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 leading role in the development and maintenance of departmental operating systems and processes.
- Assemble and lead engineering teams from within the SDT and, if required, from external suppliers, to deliver the activities and achieve project and departmental objectives.
- Ensure that products for which you are responsible are:
o robust in design through the application of appropriate engineering design and analysis, verified by the provision of objective evidence of reliability, safety and efficacy.
o conducted in compliance with SDT’s Quality Management System.
- Manage relationships with contract design houses, contract manufacturing companies and specialist external suppliers.
- Lead the engineering aspects of device safety risk management, such as design and process FMEA.
- Represent SDT in internal and external audits.
- Perform the role of independent project reviewer for device development projects in which you are not directly involved.
- Support the Engineering Manager in recruitment activities.
- Play a leading role in the continuous improvement of departmental practises:
o Support development of Standard Operating Procedures, guidelines and templates.
o Coaching and mentoring of Engineering team members and colleagues up to the level of Principal Engineer.
- Travel globally as required to support the projects, up to 25% of time out of the office. Travel might include visiting suppliers’ facilities or manufacturing sites.
- Contribute to the development of SDT’s device strategy.
- Graduate in Engineering, Scientific or other Technical discipline.
- At least 10 years relevant industry experience in product development, from concept to commercialisation.
- Previous experience in the design, manufacture and life-cycle management of medical device or combination products (preferred, or significant specialist expertise from another relevant industry).
- Recognized as an engineering authority within the organization, both within and beyond SDT.
- Knowledge of Solidworks 3D CAD (preferred).
- Specialist problem solving ability to find solutions to problems encountered with developing mechanical systems and manufacturing processes. Exhibits ingenuity, creativity and resourcefulness. Applies knowledge of highly advanced technologies, scientific principles, theories and concepts.
- Competent in the use of statistical methods, for example for the determination of design input requirements, verification and validation testing.
- Advanced skills in mentoring and coaching skills, including coaching of colleagues of senior and principal levels.
- Trusted to operate independently, with minimal guidance required.
- Provides project leadership with confidence, gravitas and charisma. Is looked to by the Engineering team for direction.
- Aptitude for working in a team environment and operating outside remit to meet deadlines when necessary.
- Ability to influence and educate at all levels.
- Confident in own judgement. Prepared to take difficult decisions and able to persuade others. Where appropriate, willing to challenge the status quo.
- Adaptable, cooperative and helpful attitude towards colleagues and customers while always acting with integrity.
- Analytical engineering assessment of mechanisms and systems.
- Good verbal and written communication including high quality engineering documentation.
- Enjoys working hard, is driven and able to challenge.
- Can effectively cope with change, coping with risk and uncertainty while comfortably adapting to changing conditions. Remains positive through adversity.
- Interfaces with, and influences, numerous other business units, including legal, commercial, drug development, operations regulatory and procurement.
- In situations where engineering 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 Engineering Manager, who reports to the Head of SDT. SDT is part of the Global R&D Innovation Technology business unit.
- Mechanical Engineering
- Medical Devices
- Product Development
- Technical Leadership
- Deisgn Control
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