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Systems Engineer – Assay Development
Tranzeal IncorporatedTucson, AZ, United Statesjob_description.job_card.variable_hours_ago
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job_description.job_card.job_descriptionBachelor’s degree in Engineering, Biomedical Sciences, or related field (Master’s 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.
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 :
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System Engineer • Tucson, AZ, United States
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