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Medical Device Embedded System Engineer Jobs in Indiana

VOLT

Medical Device Assembler

Carmel, IN · On-site

$20 - $23/hr

Follow standard operating procedures (SOPs) to ensure compliance with FDA, GMP, and quality system ... Prior experience as a Medical Device Assembler or Production Assembler is required * Ability to ...

cillium corp

Embedded Software Engineer

Michigan City, IN · On-site

$127K - $168K/yr

Clint seeking an Embedded Software Engineer to participate in the development of Silvus ... Linux system customization and scripting. Qualifications: Expert in C programming. Other language ...

Actalent

Embedded Software Engineer

Odon, IN

$65 - $80/hr

S. Navy's SPY-1 Radar System in Crane, Indiana. This engineer will play a critical role in ... Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre ...

Actalent

Embedded Software Engineer

Odon, IN

$65 - $80/hr

S. Navy's SPY-1 Radar System in Crane, Indiana. This engineer will play a critical role in ... Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre ...

ITW Avery Weigh-Tronix

Embedded Software Engineer

IN · On-site

$125K - $165K/yr

... embedded systems. Expectations: This role blends hands-on engineering with cross-functional ... collaboration, technical problem solving, product lifecycle support and software technical ...

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Medical Device Embedded System Engineer information

What does a medical device embedded system engineer do?

A Medical Device Embedded System Engineer designs, develops, and maintains the embedded software and hardware used in medical devices such as pacemakers, infusion pumps, and diagnostic equipment. They ensure that the systems meet strict safety, reliability, and regulatory standards required in the healthcare industry. Their work involves programming microcontrollers, integrating sensors and communication modules, and collaborating with cross-functional teams to ensure the final product is safe, effective, and compliant with medical regulations.

How does a medical device embedded system engineer typically collaborate with cross-functional teams during product development?

As a Medical Device Embedded System Engineer, you’ll work closely with teams such as hardware engineers, software developers, quality assurance, regulatory affairs, and clinical experts. Collaboration is essential to ensure the embedded system meets safety, performance, and regulatory requirements. This often involves participating in design reviews, troubleshooting integration issues, and providing technical documentation. Effective communication and teamwork are key, as you’ll be translating clinical needs into technical solutions and ensuring compliance with medical standards.

What are the key skills and qualifications needed to thrive as a medical device embedded system engineer, and why are they important?

A Medical Device Embedded System Engineer typically needs a strong background in electrical or computer engineering, experience with embedded C/C++ programming, and a solid understanding of medical device regulations. Familiarity with microcontrollers, real-time operating systems (RTOS), and compliance standards like IEC 62304 is highly valuable, and certifications in embedded systems or medical device software can be advantageous. Strong problem-solving skills, attention to detail, and effective teamwork are essential soft skills for excelling in this position. These competencies ensure the development of safe, reliable, and regulatory-compliant medical devices that improve patient outcomes.

What is the difference between Medical Device Embedded System Engineer vs Medical Software Engineer?

AspectMedical Device Embedded System EngineerMedical Software Engineer
CredentialsBachelor's or higher in Electrical, Computer Engineering, or related; knowledge of embedded systemsBachelor's or higher in Computer Science, Software Engineering, or related; programming skills
Work EnvironmentDesigning and testing embedded hardware/software for medical devicesDeveloping medical software applications, often on PCs or servers
Industry UsageUsed in medical devices like pacemakers, imaging equipment, and monitorsUsed in healthcare software, EHR systems, and medical data analysis

The Medical Device Embedded System Engineer focuses on developing embedded hardware and firmware for medical devices, ensuring safety and compliance. In contrast, the Medical Software Engineer primarily develops software applications used in healthcare settings. Both roles require technical expertise but differ in their focus on hardware versus software development within the medical industry.

What are popular job titles related to Medical Device Embedded System Engineer jobs in Indiana? For Medical Device Embedded System Engineer jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Medical Device Embedded System Engineer jobs in Indiana look for? The top searched job categories for Medical Device Embedded System Engineer jobs in Indiana are:
What cities in Indiana are hiring for Medical Device Embedded System Engineer jobs? Cities in Indiana with the most Medical Device Embedded System Engineer job openings:
Medical Device Embedded System Engineer jobs near you

Quality Engineer with Medical device

Kappium LLC

Warsaw, IN • On-site

Other

This job post has expired today. Applications are no longer accepted.

Job description

 Start date: 24-Aug-2026  

Location: Warsaw, Indiana (hybrid role – 3 days onsite)

Duration: 9-12 months, extensions highly likely

Job:   Quality (software)  for Medical Device software 

Software Quality Engineer – Medical Device Software Development

Job Summary

The Software Quality Engineer will provide quality leadership on cross-functional product development teams responsible for developing regulated medical device software systems. This individual will serve as a subject matter expert in software quality, requirements management, software risk management, verification and validation strategy, design controls, and defect management throughout the software development lifecycle.

Key Responsibilities

  • Support the design, development, verification, and validation of regulated medical device software, including Software as a Medical Device (SaMD).
  • Provide technical leadership and guidance on software development processes, quality systems, and best practices.
  • Partner with engineering teams to refine software requirements and ensure architecture and design documentation is complete and compliant.
  • Facilitate documentation and tracking of software verification activities, including code review findings and testing results.
  • Review software test execution results, manage software defects, and support root cause investigations.
  • Lead software risk assessment activities and develop software risk management documentation.
  • Support regulatory submissions, product registrations, and compliance documentation.
  • Support internal and external quality audits and regulatory inspections related to software products and quality systems.
  • Manage nonconformances, CAPAs, and corrective actions associated with software development activities.
  • Provide technical support for software supplier and third-party software development audits.
  • Deliver training on software development processes, quality systems, and applicable regulatory requirements.
  • Mentor junior engineers and provide guidance on software quality engineering best practices.
  • Ensure compliance with applicable software and medical device standards, including:
    • IEC 62304
    • ISO 13485
    • ISO 14971
    • IEC 62366
    • FDA Software Guidance
    • FDA 21 CFR Part 11
    • EU MDR
    • ISO 27001
    • HIPAA
  • Ensure software products meet cybersecurity, privacy, electronic protected health information (ePHI), and personally identifiable information (PII) protection requirements.
  • Collaborate with cross-functional teams to ensure compliance with company quality systems, policies, and applicable regulatory requirements.
  • Communicate project risks, quality issues, and opportunities to leadership as appropriate.
  • Follow all health, safety, environmental, and quality procedures.
  • Perform additional responsibilities as assigned.

Education & Experience

  • Bachelor’s degree in Engineering, Computer Science, Information Systems, Biomedical Engineering, or a related technical discipline required.
  • Minimum of four years of experience in a regulated industry within software quality, quality engineering, new product development, or manufacturing engineering.
  • Experience supporting software development within a regulated medical device environment.
  • Demonstrated understanding of software quality systems, design controls, software verification and validation, and risk management.
  • Experience applying quality tools, processes, and methodologies to support product development.

Required Skills & Qualifications

  • Strong understanding of the medical device software development lifecycle.
  • Experience with Software as a Medical Device (SaMD) development preferred.
  • Knowledge of software risk management, design controls, software verification and validation, defect management, and CAPA processes.
  • Familiarity with FDA and international medical device regulations and standards.
  • Strong analytical, organizational, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to work effectively on cross-functional engineering teams.
  • Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
  • ASQ Certified Software Quality Engineer (CSQE) or equivalent certification is preferred.

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