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Sr. Process Development Engineer at Access Vascular - ApplyBlast

Sr. Process Development Engineer

Access Vascular

4 months ago

4.3 on Glassdoor

Billerica, MA

Onsite

Full Time

Senior

3 applicants

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About this role

A Senior Process Development Engineer leads the design transfer and optimization of new single-use medical devices, ensuring manufacturability and compliance with FDA QMSR and ISO 13485 standards. The role involves authoring validation protocols (IQ/OQ/PQ), collaborating with cross-functional teams, and implementing automation solutions to support product launch.

Responsibilities

Lead design transfer activities from R&D to manufacturing
Execute process validation protocols including IQ, OQ, and PQ
Optimize manufacturing processes using design of experiments
Author and maintain Medical Device File documentation
Develop and implement automation solutions for production

Skills

Qualifications

BS in ManufacturingBS in Mechanical EngineeringBS in Industrial EngineeringBS in Plastics Engineering1-3 years supervisory experience

About Access Vascular

accessvascularinc.com

Headquarters

Billerica, Massachusetts, United States

Company Size

11-50 employees

Founded

2015

View Profile

Access 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.