✦ Luna Orbit — Engineering (Non-Software)

Principal R&D Engineer (Contract)

at Boston Scientific

📍 Mississauga, ON, CA Unknown Posted March 13, 2026
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Position Details

Type Contract
Experience mid
Exp. Years 6+ years
Education Bachelor's degree in Electrical, Mechanical, Systems, or Biomedical Engineering
Category Engineering (Non-Software)

About this role

This role involves leading the technical development, compliance, and lifecycle management of ultrasound console systems in a regulated medical environment.

Key Responsibilities

  • Lead product development and documentation
  • Conduct failure analyses and recommend improvements
  • Support regulatory submissions
  • Manage risk and validation activities
  • Mentor junior engineers

Technical Overview

Focus on medical device design, risk management, regulatory compliance, and lifecycle documentation, with expertise in IEC and ISO standards.

Ideal Candidate

The ideal candidate is a mid-level medical device engineer with at least 6 years of experience in regulated environments, strong knowledge of ISO 13485 and IEC standards, and proven leadership in product development and risk management.

Must-Have Skills

Bachelor's degree in ElectricalMechanicalSystemsor Biomedical Engineering6+ years product development in regulated industryKnowledge of ISO 13485Experience with IEC 60601-1 and IEC 60601-1-2 standardsExperience leading hardware and software development

Nice-to-Have Skills

Medical device lifecycle managementRegulatory submissionsSupply chain interfaceDesign for manufacturability (DFM)

Tools & Platforms

ISO standardsIEC standardsregulatory documentation tools

Required Skills

ISO 13485IEC 60601-1IEC 60601-1-2failure analysisverification and validationDHFDMRrisk managementFMEAPFMEAmedical device engineering

Hard Skills

ISO 13485IEC 60601-1IEC 60601-1-2product developmentregulatory standardsrisk managementFMEAPFMEAdesign history filesDHFdevice master recordsDMRfailure analysisverification and validationmedical device engineering

Soft Skills

strategic problem-solvingcross-functional collaborationleadershipmentorshipcommunication

Industry & Role

Industry Healthcare & Medical
Job Function Medical device engineering and lifecycle management

Keywords for Your Resume

Principal R&D Engineermedical device engineeringISO 13485IEC 60601-1IEC 60601-1-2failure analysisverification and validationDHFDMRrisk managementFMEAPFMEAregulatory standardsproduct developmentmedical device lifecycleregulatory submissions

Deal Breakers

Lack of experience with IEC 60601 standards, No background in medical device regulation, Less than 6 years of relevant experience, No Bachelor's degree in engineering

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