Principal Clinical Systems Engineer

3 weeks ago

Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Job Title: Principal Clinical Systems Engineer

We are seeking a highly skilled Principal Clinical Systems Engineer to join our team at Waters Corporation. As a key member of our Clinical Business Unit, you will play a critical role in defining our products and ensuring that developments meet the highest standards of safety and effectiveness.

Responsibilities:
  • Contribute to the development of Liquid Chromatography Mass Spectrometry (LC-MS) Systems, working closely with cross-functional teams to translate customer requirements into system designs.
  • Collaborate with product owners to understand and define system context, and develop user requirements that meet the needs of our customers.
  • Lead the development and support of existing Waters Clinical systems and technologies, ensuring that they meet the highest standards of quality and safety.
  • Take ownership of system verification and validation documents, providing test evidence that system design requirements have been met.
  • Promote the use of systems engineering tools, processes, and practices, including modelling or simulation of emergent system behaviour where appropriate.
  • Work within our process and regulatory frameworks, ensuring that consideration of risk and patient safety are at the core of our products.
Qualifications:
  • Bachelor's degree or equivalent experience in Engineering, Physics, Chemistry, or a related subject. A Master's degree in Systems Engineering would be desirable.
  • Experience working in a multi-disciplinary engineering team environment, particularly with proven practical experience of LC and/or mass spectrometry or a related discipline.
  • Proven experience in the development of LC and/or MS instrumentation, or similar scientific or analytical instrumentation containing sample preparation, chemistry, fluids under pressure, optics, vacuum, particle optics, precision mechanics, electronics, and firmware/software.
  • Experience in working with complex systems, including a proven ability to understand high-level software and electro-mechanical architecture.
  • Ability to work in a regulated environment within a process.
  • Technical understanding of the requirements, procedures, and physical resources needed to verify sub-assemblies in system environments and complete LC/MS products.
  • Ability to network and build cross-functional teams.
  • Excellent written and oral communication skills, with the ability to generate succinct reports and communicate effectively with staff, peer groups, and other stakeholders.
  • Ability to work independently and communicate with all levels of the organisation.
  • Computer literate, with knowledge of Word, PowerPoint, and Excel an advantage.
  • Fluency in Mandarin Chinese would be an advantage.

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