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Medical Device Embedded System Engineer Jobs in Mason, OH

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Medical Device Embedded System Engineer information

See Mason, OH salary details

$58.8K

$129.1K

$180.6K

How much do medical device embedded system engineer jobs pay per year?

As of Sep 3, 2026, the average yearly pay for medical device embedded system engineer in Mason, OH is $129,091.00, according to ZipRecruiter salary data. Most workers in this role earn between $104,900.00 and $153,800.00 per year, depending on experience, location, and employer.

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 Mason, OH?

For Medical Device Embedded System Engineer jobs in Mason, OH, the most frequently searched job titles are:

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What cities near Mason, OH are hiring for Medical Device Embedded System Engineer jobs?

Cities near Mason, OH with the most Medical Device Embedded System Engineer job openings:

Medical Device Embedded System Engineer jobs near you

Medical Device Component Development Engineer

PB consulting

Camp Dennison, OH

Full-time

Posted 27 days ago

Job description

We are seeking a Medical Device Component Development Engineer to support component development, product lifecycle management, and engineering change activities for regulated medical devices. The ideal candidate will have expertise in design controls, verification & validation, supplier quality, process validation, and regulatory compliance.

Roles and Responsibilities
  • Lead component development and engineering change projects from concept to implementation.
  • Manage project timelines, risks, and cross-functional coordination.
  • Support Design Verification & Validation (V&V), test protocols, and technical documentation.
  • Partner with suppliers on component qualification, DFM reviews, tooling, and process capability.
  • Support manufacturing transfer, IQ/OQ/PQ, pilot builds, and production readiness.
  • Apply Design Controls, PLM, ECO/ECN/ECR, Risk Management, and Quality System requirements.
  • Review engineering drawings, GD&T, specifications, and acceptance criteria.
  • Drive root cause analysis using CAPA, 8D, 5 Whys, and Fishbone methodologies.
  • Communicate project status, risks, and technical recommendations to stakeholders.
Required Qualifications
  • Experience in Medical Device Component Development or Product Development.
  • Strong knowledge of:
    • Product Lifecycle Management (PLM)
    • Design Controls & Engineering Change Management (ECO/ECN/ECR)
    • Design Verification & Validation (V&V)
    • ISO 14971, DFMEA, PFMEA
    • ISO 13485 & FDA 21 CFR Part 820/QMSR
    • Supplier Quality Engineering & Design for Manufacturability (DFM)
    • Process Validation (IQ/OQ/PQ)
    • GD&T and engineering drawings
  • Strong project management, communication, and problem-solving skills.
  • Experience working with cross-functional teams in a regulated medical device environment.
Preferred Skills
  • Medical Device Product Development
  • Supplier Quality & Component Qualification
  • Risk Management & Regulatory Compliance
  • Manufacturing Transfer & Validation
  • Root Cause Analysis (CAPA, 8D)
  • Stakeholder & Project Management

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