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Device Development Engineer

INA Solution

  • North Attleborough, MA
  • 1 day ago
  • $80,000–$159,999.96 Per Year
  • Full-time

Highlights

This role involves hands-on product design, prototyping, testing, manufacturing process optimization, and supporting products throughout the entire development lifecycle, from initial concept to commercial production, within a regulated medical device environment. We are looking for an experienced Interventional Device Development Engineer to drive the design and development of advanced medical devices, with a primary focus on catheter and guidewire technologies.

Numbers & Facts

LocationNorth Attleborough, MA
Job TypeFull-time
Salary$80,000–$159,999.96 Per Year
Additional CompensationBonus

Description

We are looking for an experienced Interventional Device Development Engineer to drive the design and development of advanced medical devices, with a primary focus on catheter and guidewire technologies. This role involves hands-on product design, prototyping, testing, manufacturing process optimization, and supporting products throughout the entire development lifecycle, from initial concept to commercial production, within a regulated medical device environment.

Job Responsibilities

  • Design and develop catheters, guidewires, and electromechanical medical devices from concept to commercialization.
  • Develop prototypes, perform engineering analysis, and optimize product designs.
  • Support manufacturing processes such as extrusion, reflow, bonding, tipping, and precision assembly.
  • Execute DOE, feasibility studies, and verification & validation (V&V).
  • Conduct FMEA, risk assessments, design reviews, and root-cause analysis.
  • Prepare and maintain DHF, DMR, BOMs, drawings, test protocols, and engineering reports.
  • Drive DFM, process optimization, manufacturing transfer, and product commercialization.
  • Coordinate project timelines, budgets, technical deliverables, and client communications.
  • Ensure compliance with FDA, ISO 13485, MDR, and applicable quality standards.

Qualifications

  • Bachelor's degree in Biomedical, Mechanical, Manufacturing, Plastics, Polymer Engineering, or a related field.
  • Experience in medical device design and development, preferably involving catheters or guidewires.
  • Previous experience in a contract design or manufacturing environment is an advantage.
  • Hands-on expertise in product prototyping, testing, development, and manufacturing processes.
  • Strong engineering, troubleshooting, and root-cause analysis skills.

About Company

Aviation and Aerospace Component Manufacturing Shop

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