Principal Engineer


Our client a multinational healthcare company are currently seeking a Principal R&D Engineer to join their team. The Principal Engineer will Report to an R&D Director and will work on development of portfolio of devices and be R&D Subject Matter Expert in the organization.


Role/Responsibilities

• Responsible for providing technical leadership to support device development across portfolio.
• Development of the device design requirements and specifications and for performing robust device and product characterization throughout the design development program.
• Responsible for technical interface between drug product and device teams during combination product development on elements such as primary container interface and compatibility, exhibit batch manufacture and shelf life studies.
• Provide technical support to manufacturing sites during filling and assembly process development. Responsible for designing experiments and manufacturing trials to identify process controls, reliability requirements, sampling plans and release specifications.
• Responsible for metrology, engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/ leachable, specifications & method development and transport & shipping studies.
• Trending and statistical analysis of analytical and manufacturing data including compilation of technical reports to support combination product development lifecycle.
• Responsible for critical review of the device analytical and manufacturing control strategy for projects by ensuring regulatory requirements are incorporated into development plans.
• Responsible for compilation and review/approval of technical documentation within the group
• Ensures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management system.

• The ideal candidate will be a qualified, experienced professional with a proven track record of success, a positive attitude and who wants to progress in a fast-paced environment.
• Masters/Degree in Engineering/Science with 7 years’ experience in a late stage R&D or Technical Support environment
• Previous experience of working as an Engineer or Scientist role in a regulated and GMP environment on injectable devices
• Previous experience in compiling analytical and/or manufacturing control sections of regulatory submissions is desirable
• A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
• Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role
• It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
• Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders
• Some travel will be required as part of this role