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Gabriele & Company

Senior Process Engineer

Gabriele & Company, Northborough, Massachusetts, us, 01532

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Senior Process Engineer - Cardiac Catheters

$110K-$140K + 10% Bonus | Northborough, MA | Direct Hire | No visa, No relocation |

Established cardiac device manufacturer developing advanced ablation catheter technology seeks Senior Process Engineer for R&D team. Focus on process development, scale-up, and commercialization of complex single-use catheters.

Core Responsibilities

Design for manufacturing and scalability of catheter assemblies

Develop and optimize catheter fabrication processes : bonding, reflow, tip forming, extrusion

Transfer processes from R&D to production with full documentation

Create fixtures, prototypes, and manufacturing aids using SolidWorks

Execute DOE, process validation, and statistical analysis

Collaborate with component vendors on catheter materials and components

Required Experience

BS / MS in Mechanical, Manufacturing, or Biomedical Engineering

6+ years hands-on catheter development (vascular, cardiac, or endoscopic catheters)

Direct experience with catheter fabrication processes and equipment

Working knowledge of catheter materials : Pebax, PTFE, polyimide, Nitinol

SolidWorks proficiency and statistical process control

Medical device regulatory environment (FDA, ISO 13485)

Ideal Background

Process engineering at catheter manufacturers or contract manufacturers

Experience with interventional or diagnostic catheters

R&D / development focus (not production support)

What We Offer

Base : $110K-$140K depending on experience

10% annual performance bonus

Comprehensive benefits package

R&D-focused role with technical growth

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