Systems Engineering Expert

1 day ago

Sydney, New South Wales, Australia beBeeSystem Full time $120,000 - $140,000
Job Title: Systems Integration Engineer – Process

We are seeking a solutions-focused engineer to join our dynamic team. This role plays a key part in gathering and documenting requirements for workflows, enabling us to bring innovative technologies to customers, driving better patient care and outcomes.

Our company improves patient care and outcomes by developing diagnostic technologies that simplify molecular pathology.

Responsibilities of this role include:

  • Gathering requirements by drafting product requirements from customer needs, including workflow, reagents, hardware, and software requirements.
  • Authoring and reviewing software and technical requirement specifications.
  • Designing and generating traceability matrices for requirements and test cases.
  • Acting as a technical contact for internal/external customers and suppliers during product development.
  • Consulting with external design engineers and OEM vendors to understand system functionality and coordinate the implementation of requirements and design specifications.
  • Reviewing test cases authored by other experts to verify requirements.
  • Understanding business needs and designing integration solutions by analyzing data formats and functionalities.
  • Coordinating and executing activities for test campaigns to verify requirements and ensure conformance.
  • Developing reports to support system verification and validation.
  • Conducting reliability, testability, fault tolerance, and system stress analyses on diagnostic instrument systems.
  • Reviewing or developing detailed Failure Modes and Effects Analyses (FMEA) of systems.

To be successful in this role, you will need to possess:

  • Knowledge of molecular biology, including real-time PCR.
  • Experience in engineering or validation for IVDs or regulated products.
  • Experience in software, product, process, or equipment validation.
  • Familiarity with requirements management software.
  • A process- and solution-oriented mindset.
  • Strong written and verbal communication skills.
  • The ability to work independently and as part of a team.

You should also hold a bachelor's degree in science, engineering, or a related field; a master's or PhD is advantageous.

Experience in validating products/services in diagnostics or life sciences, and knowledge of methylation, is a plus.

We are committed to equal employment opportunities, valuing diversity and encouraging talented individuals to apply.

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