Senior Designs Assurance Quality Engineer
Access Vascular(2 days ago)
About this role
This role involves managing design control, product design, and risk management processes for medical devices including software and electromechanical products. The individual will support product development projects from concept to launch, ensuring compliance with regulatory standards and quality systems.
Required Skills
- FDA
- ISO 13485
- Risk Management
- Design Control
- Software Development
- Validation
- Cybersecurity
- Statistical Analysis
- Failure Analysis
- Manufacturing
About Access Vascular
accessvascularinc.comAccess Vascular develops novel hydrophilic biomaterial vascular access devices, including a midline catheter (HydroMID) and peripherally inserted central catheter (PICC). Their biomaterial is engineered to significantly reduce complications — data cited show up to 6x fewer complications with HydroMID and 99.99% less bacterial adhesion versus polyurethane in a blood-loop model. The company targets hospitals and infusion providers to improve patient outcomes and lower infection and complication rates across acute and home-care settings. Clinical evidence and material innovation are positioned as their core differentiators in transforming vascular access outcomes.
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