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Medical Device Embedded Software Engineer Jobs in Gainesville, FL

Exactech

QA PM Specialist

Gainesville, FL · On-site

... Medical Device or Pharmaceutical FDA regulated environment. * In lieu of previous complaint ... Experience with quality system management software highly preferred. Functional/Technical Knowledge ...

Advita Ortho

QA PM Specialist

Gainesville, FL · On-site

$65 - $95/hr

... Medical Device or Pharmaceutical FDA regulated environment. * In lieu of previous complaint ... Experience with quality system management software highly preferred. Functional/Technical Knowledge ...

Advita Ortho

Manager, Quality Engineering

Gainesville, FL · On-site

$90 - $120/hr

Manager, Quality Operations Engineering Department: Quality Employment Type: Full Time Location ... Minimum of 7 years experience, preferably in orthopedic or other medical device field. * Working ...

TCAVI

Device Technician (ICD/Pacemaker)

Gainesville, FL · On-site

$60 - $90/hr

... Medical Assistant to join our company as a DEVICE TECHNICIAN (Pacemakers and ICD) in the DEVICE ... Device Programming: Collaborate with the cardiology team to assist in patient management and ...

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Evergen

Sr. Quality Engineer

Alachua, FL · On-site

$90K - $115K/yr

Bachelor's degree in relevant technical discipline Experience * 6+ years of relevant medical device ... Quality Management System software * Investigations * Statistical techniques Travel * N/A SAFETY ...

Advita Ortho

Senior Principle PM Data Analyst

Gainesville, FL · On-site

$77K - $97K/yr

Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering ... Expert knowledge of global medical device post-market surveillance and quality-system expectations ...

Exactech

Senior Principle PM Data Analyst

Gainesville, FL

$77K - $98K/yr

Bachelor's degree in Biomedical Engineering, Life Sciences, Data Science, Statistics, Engineering ... Expert knowledge of global medical device post-market surveillance and quality-system expectations ...

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All JobsMedical Device Embedded Software Engineer JobsMedical Device Embedded Software Engineer Jobs in Gainesville, FL

Medical Device Embedded Software Engineer information

See Gainesville, FL salary details

$63.4K

$139K

$157.6K

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

As of Sep 3, 2026, the average yearly pay for medical device embedded software engineer in Gainesville, FL is $138,966.00, according to ZipRecruiter salary data. Most workers in this role earn between $119,100.00 and $156,700.00 per year, depending on experience, location, and employer.

What is a medical device embedded software engineer?

Medical Device Embedded Software Engineers are professionals who design, develop, and maintain the specialized software that runs on hardware inside medical devices, such as pacemakers, infusion pumps, and imaging machines. They ensure that the software meets strict regulatory standards for safety, reliability, and performance. Their work involves programming, testing, debugging, and documenting embedded code, as well as collaborating with hardware engineers and regulatory teams to bring safe and effective medical products to market.

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

To thrive as a Medical Device Embedded Software Engineer, you need a strong background in embedded systems design, C/C++ programming, and a degree in electrical engineering, computer engineering, or a related field. Familiarity with real-time operating systems (RTOS), hardware-software integration, and industry standards like IEC 62304 or FDA regulations is typically required. Attention to detail, strong problem-solving abilities, and effective teamwork are vital soft skills for this role. These competencies are crucial for developing reliable, safe, and compliant software that meets stringent healthcare requirements.

What are some common challenges faced by medical device embedded software engineers when working on cross-functional teams?

Medical Device Embedded Software Engineers often collaborate closely with hardware engineers, regulatory specialists, and quality assurance teams. A common challenge is ensuring that software requirements align with hardware limitations and regulatory standards, which can necessitate frequent adjustments and clear documentation. Additionally, balancing the pace of software development with the rigorous testing and validation processes required for medical devices can be demanding. Effective communication and adaptability are essential to navigate these multidisciplinary interactions and deliver safe, compliant products.

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

AspectMedical Device Embedded Software EngineerFirmware Engineer
CredentialsBachelor's in Electrical, Computer Engineering, or related; often certifications in medical device standardsBachelor's in Electrical, Computer Engineering, or related; certifications vary by industry
Work EnvironmentMedical device companies, regulated environments, quality assurance focusConsumer electronics, industrial, or embedded systems companies
Industry UsagePrimarily in healthcare, medical device manufacturingBroader tech sectors, including consumer electronics and industrial systems
Search & Comparison IntentHigh overlap in embedded systems, safety standards, and certification requirements

The Medical Device Embedded Software Engineer and Firmware Engineer roles share core skills in embedded systems development. However, the Medical Device Embedded Software Engineer focuses specifically on medical device safety, regulatory compliance, and working within healthcare environments. Firmware Engineers may work across various industries without the strict medical standards, making the Medical Device Embedded Software Engineer role more specialized in healthcare applications.

What are popular job titles related to Medical Device Embedded Software Engineer jobs in Gainesville, FL?

For Medical Device Embedded Software Engineer jobs in Gainesville, FL, the most frequently searched job titles are:

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Cities near Gainesville, FL with the most Medical Device Embedded Software Engineer job openings:

Medical Device Embedded Software Engineer jobs near you

Manager, Quality Engineering

Advita Ortho

Gainesville, FL • On-site

Full-time

Re-posted 20 days ago

Job description

Manager, Quality Engineering
Department: Quality
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Director, Quality Management Systems
Description
The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.
Key Responsibilities
  • Quality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance.
  • Quality Engineering Leadership: Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives.
  • Product Realization (Design & Manufacturing): Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&T, inspection, and statistical requirements.
  • CAPA & Investigations: Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues.
  • Complaints & Nonconformance: Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed.
  • Data & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality Governance.
  • Audit Support: Serve as SME during internal and external audits/inspections.

Skills Knowledge and Expertise
Education:
  • Bachelor's Degree in Science from an accredited institution required; Master's Degree preferred

Experience:
  • Minimum of 7 years experience, preferably in orthopedic or other medical device field.
  • Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.
  • Minimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.
  • Experience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications
  • Prior audit experience with FDA and notified bodies.

Functional/Technical Knowledge, Skills and Abilities Required:
  • Excellent verbal, written communication and leadership skills.
  • Ability to work with all organizational functions.

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