R&D Engineer in development of IVD medical devices
R&D Engineer (Permanent role)
Purpose of job
The primary responsibility of the R&D Engineer will be the ongoing development of the current Haemostasis IVD products in Tcoag and future range of instruments, assays and systems. This will include but not be limited to the design, planning, execution and co-ordination of all development, verification and validation activities associated with the development and upgrade of our product range in a Design Control regulated environment.
The R&D Engineer must be a good project planner and have the ability to work closely with other Tcoag groups (Marketing, Instrument Manufacturing, Reagent Production and also assist and support GSA as required) and external consultants.
Initial assignments will include being an integral part of the R&D Development team, evaluation and testing of new Instrument Software modifications including debugging, writing protocols, and assisting the development of the next generation of Haemostasis Instruments and reagents. This may require the successful candidate to travel regularly to other Tcoag facilities and Customer sites. A background in Software development, verification and validation is key for this role.
- Must be able to deliver Design Control activities (e.g. Verification and Validation) in accordance with project milestones.
- Manage the compilation of Design History Files and Design Change Control files in accordance with ISO and FDA requirements.
- Design, review and perform appropriate Development and Verification testing of next generation instruments and sub assemblies.
- Design, review and perform appropriate Validation plans, protocols and reports of next generation instruments and sub assemblies.
- Co-ordinate root cause investigations and reporting on system related failures as identified through such channels as validation, customer complaints, service histories or CAPAs.
- Define and implement Standard Policies and Procedures as required.
- Provide training and support to internal users on the design and functionality of our instruments.
- Active Team member
- Collate and manage feedback from Technical Service, End Users and Distributors to drive continuous improvement in our product range.
- Third level Mechanical, Electronic or Software Engineering degree with 3+ years experience in Instrumentation Design, Manufacture or Validation
- Working knowledge of FDA and ISO Quality System Requirements as they relate to Diagnostic Instrumentation
- Demonstrated ability to work successfully on projects across multiple functions and sites
Skills and Behaviours
- Excellent written and verbal communication skills with specific emphasis on technical report writing.
- Must be able to work with minimal supervision as an individual or as a team member.
- Problem Solving / Root Cause investigation.
- Strong attention to detail/quality.
A working knowledge of French and or German would also be a distinct advantage.