Access Vascular
Recruiter Contact
Darwin Shurig
Chief Executive Officer
Transforming Vascular Access
Access Vascular was founded to address the most common and costly complications of intravenous therapy: infection, thrombosis, and phlebitis. Taking a foundationally different approach to thrombus reduction, the company manufactures intravenous catheters from a hydrophilic material which retains significant amounts of water. Engineered to mimic the body’s natural chemistry, Access Vascular catheters are designed to evade the foreign body response and complications that come with it. Our cleared products are HydroPICC®and HydroMID®.
Video- message from the CEO/Founder
The Opportunity
Design Quality Assurance Engineer II or Sr Design Quality Assurance Engineer
Facility location: Billerica, MA-
Interview with the Hiring Manager
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Summary of Opportunity
Access Vascular has an impressive proprietary technology, has demand for additional products, and has had five 510 (k) submissions approved by the FDA. This will be the 4th position on the quality team and report into the Head of Quality to support FDA compliance with design controls, risk management, TMV, dFMEA, and the Design History File. This is a high visibility opportunity in a great culture, includes equity, and room for career growth.
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The Right Talent
- BS Degree in Engineering, Science, or Relevant Degree and experience
- 3+ Years of Design Quality Engineering experience in the Medical Device or Biotech industries
- Experience with Design Control inputs/outputs, Design V&V, TMV, and Risk Management
- Understanding of ISO 13485 and 14971
- Experience with data analysis, statistical analysis, and Minitab preferred
- Strong problem-solver, team player, and energy
- Adaptability and can work in a fast-paced, growth environment
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Access Vascular Inc. Named 2022 MedTech Breakthrough Award Winner
Access vascular Receives FDA Clearance for HydroPICC Biomaterial- Based Dual-Lumen Catheter
Access Vascular, Inc. Opens New Facility Outside Boston With Expanded Production Capacity to Meet Growing Demand for Its Biomaterial Devices
Access Vascular, Inc. Secures $20 Million in Series B Financing