Systems Integration Engineer – Process

2 weeks ago

Sydney, New South Wales, Australia Genetic Signatures Ltd. Full time

We are seeking a solutions-focused Systems Integration Engineer – Process to join our dynamic Systems Integration team. This role plays a key part in gathering and documenting requirements for workflows (reagents, software, and hardware) in our development pipeline, enabling Genetic Signatures to bring its innovative molecular diagnostic technology to customers, driving better patient care and outcomes.

Genetic Signatures improves patient care and outcomes by developing innovative diagnostic technologies that simplify molecular pathology.

We are an Australian-based manufacturer selling into leading pathology laboratories in Australia and distributing worldwide. We are looking to expand our diverse, supportive, and talented team.

In this role, you will be responsible for:

  • 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, you will 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.

Genetic Signatures Ltd is committed to equal employment opportunities, valuing diversity and encouraging talented individuals to apply. Due to physical demands, a pre-employment medical assessment is required.

The successful candidate will receive a competitive remuneration package commensurate with experience.

If you're interested in making a difference in healthcare outcomes, apply now. We look forward to hearing from you

Please apply with a cover letter and CV via the provided link or Seek. For inquiries, email careers@geneticsignatures.com. Only shortlisted candidates will be contacted.

We are committed to diversity and equal opportunity in employment, welcoming applicants regardless of race, color, religion, national origin, gender, age, sexual orientation, gender identity, disability, veteran status, or other protected classes.

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