Principal Clinical Systems Engineer

2 days ago

Wilmslow, Cheshire East, United Kingdom Waters Corporation Full time
Responsibilities

As a Systems Engineer within the Clinical team, your key responsibilities will include:

  • Contributing to the development of Liquid Chromatography Mass Spectrometry (LC-MS) Systems for the Clinical Business Unit, playing a critical role in defining our products by translating customer requirements into system design specifications and ensuring that developments meet safety and effectiveness standards.
  • Collaborating with product owners to understand and define system context and user requirements, and working closely with cross-functional teams to generate system designs and architectures.
  • Leading the development and support of existing Waters Clinical systems and technologies, and promoting the use of systems engineering tools and practices.
  • Ensuring that system verification and validation documents provide test evidence that system design requirements have been met, and working within regulatory frameworks to ensure patient safety.
  • Working within a multi-disciplinary engineering team environment, particularly with experience of LC and/or mass spectrometry or related disciplines, and having a 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, and excellent written and oral communication skills to ensure effective communication with staff, peer groups, and other stakeholders.
Qualifications

We're looking for candidates with:

  • A bachelor's degree or equivalent experience in Engineering, Physics, Chemistry, or a related subject, with a Master's degree in Systems Engineering being desirable.
  • Experience working in a regulated environment, particularly with complex systems, and a proven ability to understand high-level software and electro-mechanical architecture.
  • Ability to work independently and communicate with all levels of the organisation, and fluency in Mandarin Chinese being an advantage.

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