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Systems Engineer Assay Development (Tucson)

Systems Engineer Assay Development (Tucson)

Tranzeal IncorporatedTucson, AZ, US
17 hours ago
Job type
  • Part-time
Job description

Systems Engineer Assay Development

We are seeking a Systems Engineer to join an innovative R&D team focused on advancing diagnostic and assay development solutions. The ideal candidate will drive system-level requirements, risk management, and verification / validation (V&V) processes across the product lifecycle, ensuring compliance with regulatory standards and alignment with business and customer needs.

Key Responsibilities :

  • Lead system engineering activities, including requirements definition, risk assessment, and V&V planning / execution.
  • Collaborate cross-functionally with R&D, Quality, Regulatory, and Operations teams to ensure technical and compliance alignment.
  • Analyze technical challenges, propose robust solutions, and drive decision-making for system-level tradeoffs.
  • Research emerging technologies and trends to enhance system performance and reliability.
  • Maintain documentation traceability through tools such as RETINA or equivalent systems.

Qualifications :

  • Bachelors degree in Engineering, Biomedical Sciences, or related field (Masters or PhD preferred).
  • 4+ years of experience in systems engineering or assay development within a medical device or diagnostics environment .
  • Strong understanding of IVD standards , FDA / ISO regulatory frameworks , and risk management methodologies (e.g., FMEA) .
  • Experience with requirements management , configuration control , and V&V test strategy development .
  • Excellent organizational, problem-solving, and communication skills with the ability to manage multiple priorities.
  • Experience in cytology assay development or clinical workflow applications.
  • Familiarity with LucidChart / LucidSpark or similar visualization tools.
  • Working knowledge of software, electronics, and electro-mechanical systems as they relate to diagnostic instruments.
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    System Engineer • Tucson, AZ, US

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