✦ Luna Orbit — Engineering (Non-Software)

Embedded Software Engineer III

at Boston Scientific

📍 Arden Hills, MN, US, 55112 Hybrid Posted March 13, 2026
Type Full-Time
Experience mid
Exp. Years 3+ years
Education Not specified
Category Engineering (Non-Software)

This role involves developing and integrating firmware for active implantable medical devices, ensuring compliance with industry standards and regulations, and collaborating across teams for device safety and performance.

  • Develop firmware architectures
  • Ensure regulatory compliance
  • Support system integration
  • Mitigate firmware risks
  • Collaborate with cross-functional teams

Proficient in embedded systems, firmware architecture, IEC 62304, ISO 13485, ISO 14971, and FDA regulatory requirements for medical devices.

The ideal candidate is an embedded software engineer with at least 3 years of experience developing firmware for medical devices, familiar with IEC 62304, ISO 13485, and FDA regulations, capable of system integration and risk mitigation.

Experience in embedded firmware developmentKnowledge of IEC 62304Understanding of FDA regulationsExperience with ISO 13485 and ISO 14971
Cybersecurity standardsSystem integration experienceMedical device development experience
IEC 62304ISO 13485ISO 14971FDA regulations
Embedded systemsFirmware developmentIEC 62304ISO 13485ISO 14971FDA regulationsCybersecurity standardsSystem integrationMedical device development
Embedded systemsFirmware developmentReal-time systemsIEC 62304ISO 13485ISO 14971FDA regulationsCybersecurity standardsSystem integrationMedical device development
collaborationproblem-solvingattention to detailregulatory awarenessteamwork
Industry Medical Devices
Job Function Firmware development and system integration for medical devices
Embedded Software EngineerFirmware developmentReal-time systemsIEC 62304ISO 13485ISO 14971FDA regulationsCybersecurity standardsSystem integrationMedical device developmentEmbedded systemsFirmware architectureRisk managementRegulatory compliance

Lack of embedded firmware experience, No knowledge of IEC 62304 or ISO standards, No experience with FDA regulations, Unfamiliar with medical device development

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