Device Development Engineer

Job Title: Interventional Device Development Engineer Levels I IV / Principal

Location: North Attleboro, MA
Employment Type: Full-Time
Industry: Medical Device / Interventional Device Development

Job Summary

We are seeking an Interventional Device Development Engineer to design, develop, optimize, and transfer innovative interventional medical devices from concept through commercialization. This role will focus on catheter and guidewire technologies , hands-on prototyping, process development, testing, and full product lifecycle support within a highly regulated medical device environment.

The position is available at Levels I IV through Principal , with responsibilities and technical leadership expectations increasing based on experience.

Key Responsibilities

• Design and develop catheters, guidewires, and electromechanical medical devices from concept through commercialization.
• Generate concepts, perform engineering analysis and modeling, build prototypes, and evaluate designs against performance, regulatory, and manufacturing requirements.
• Develop and optimize manufacturing and assembly processes, including:
  • Extrusion
  • Reflow
  • Bonding
  • Tipping
  • Precision assembly
• Support product development projects, including timelines, deliverables, project plans, budgets, and technical proposals.
• Execute Design of Experiments (DOE) , feasibility studies, verification, and validation activities.
• Perform risk analysis, including FMEA , and participate in design reviews.
• Create and maintain technical documentation, including DHF, DMR, drawings, BOMs, protocols, and engineering reports .
• Support prototype fabrication, testing, troubleshooting, root-cause analysis, and continuous improvement.
• Collaborate with manufacturing, quality, engineering, suppliers, consultants, and other cross-functional teams.
• Work directly with clients to communicate project status, technical findings, solutions, and development milestones.
• Support manufacturing transfer, process scale-up, and commercialization activities.
• Apply Design for Manufacturability ( DFM ) principles throughout product development.
• Ensure development activities comply with applicable FDA, ISO 13485, MDR, and quality-system requirements .

Required Qualifications

• Bachelor's degree in Biomedical, Mechanical, Manufacturing, Plastics, Polymer Engineering , or a related engineering discipline.
• Experience in medical device product development ; catheter or guidewire experience is highly preferred.
• Experience with a contract design and manufacturing environment is preferred.
• Hands-on experience with product development, prototyping, testing, and manufacturing processes.
• Strong understanding of engineering problem-solving and root-cause analysis.
• Excellent written, verbal, technical communication, and interpersonal skills.

Key Technical Skills

• Medical Device Product Development
• Catheter & Guidewire Engineering
• Design Controls
• Product Lifecycle Management
• Design for Manufacturability (DFM)
• Design of Experiments (DOE)
• Verification & Validation (V&V)
• Risk Management / FMEA
• Polymer and Metal Materials
• Extrusion, Reflow, Bonding & Tipping
• Precision Assembly
• Process Development & Optimization
• Manufacturing Transfer & Scale-Up
• Prototype Development & Testing
• Root Cause Analysis
• DHF / DMR / BOMs
• FDA / ISO 13485 / MDR
• Statistical Analysis and Data Interpretation
• Supplier Collaboration

Level Expectations

Level I

• Foundational engineering knowledge and understanding of medical device development.
• Supports prototyping, testing, documentation, and development activities.
• Develops familiarity with regulatory and quality-system requirements.

Level II

• Independently performs routine product and process development activities.
• Applies engineering principles to solve technical problems.
• Contributes to development projects with limited supervision.

Level III

• Provides advanced engineering and product development expertise.
• Leads technical workstreams and mentors junior engineers.
• Demonstrates strong knowledge of design controls, risk management, and validation.

Level IV

• Serves as technical lead for complex development programs.
• Provides expert engineering judgment and technical direction.
• Leads customer interactions and cross-functional development activities.

Principal Engineer

• Serves as a subject matter expert in interventional device technologies.
• Establishes technical direction and drives innovation.
• Provides strategic technical guidance to key clients and development programs.
• Develops organizational technical capabilities and mentors engineering teams.