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Medical Device Embedded Software Engineer Jobs in Gainesville, FL

Design Engineer, Packaging

Gainesville, FL ยท On-site

$122K/yr

Manager, End of Line Engineering Description Design and development of medical device packaging or ... Must have knowledge of various software packages including Microsoft Office applications. Knowledge ...

Design Engineer, Packaging

Gainesville, FL ยท On-site

$123K/yr

Design and development of medical device packaging or sterilization cases. Includes qualification ... Must have knowledge of various software packages including Microsoft Office applications. Knowledge ...

Intern - Eng Test Lab

Gainesville, FL

$15.25 - $19.75/hr

Apply engineering acumen to evaluate impact of revisions to technical standards on medical device ... Computer aided design software * Motivated to take initiative and work effectively in teams

Intern - Eng Test Lab

Gainesville, FL ยท On-site

$15 - $19.50/hr

Apply engineering acumen to evaluate impact of revisions to technical standards on medical device ... Computer aided design software * Motivated to take initiative and work effectively in teams

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

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

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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 Aug 12, 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 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 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 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:
What job categories do people searching Medical Device Embedded Software Engineer jobs in Gainesville, FL look for? The top searched job categories for Medical Device Embedded Software Engineer jobs in Gainesville, FL are:
What cities near Gainesville, FL are hiring for Medical Device Embedded Software Engineer jobs? Cities near Gainesville, FL with the most Medical Device Embedded Software Engineer job openings:

Design Engineer, Packaging

Advita Ortho

Gainesville, FL โ€ข On-site

$122K/yr

Full-time

Posted 16 days ago


Job description

Design Engineer, Packaging
Department: Manufacturing Engineering
Employment Type: Full Time
Location: Gainesville, FL
Reporting To: Manager, End of Line Engineering
Description
Design and development of medical device packaging or sterilization cases. Includes qualification/testing of packaging configurations and process validation.
Key Responsibilities
  • Under supervision, design and develop package or sterilization case components for new or existing products.
  • Define the design input requirements for medical-device packaging or sterilization case components through consultation with end users and other stakeholders (e.g., nurses, Sales, Marketing, Development, Quality, Manufacturing and Distribution personnel). These design inputs should take into consideration function, reliability, cost and company image.
  • Prepare specifications for the raw materials, components and processes for medical-device packaging or sterilization case components.
  • Execute test protocols for medical-device packaging or sterilization cases components.
  • Document sterile product bills of material and shelf life.
  • Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).
  • Complete all Design Control activities for projects as required.
  • Maintain and improve existing packaging or sterilization case systems.
  • Apply sound engineering problem-solving techniques to package/case development and maintenance tasks including design, statistical analysis, material selection, inspection requirements and manufacturing process requirements.
  • Prepare and submit written and oral communications that describe package/case design concepts, attributes and performance and project status. Areas of involvement include regulatory submissions, Design History Files, package/case evaluation, package/case validation and testing, manufacturing or supplier support, quality control and complaint evaluation.
  • Consult with vendors, as required, regarding the technical aspects of design and development projects.
  • Assure timely and effective project completion according to the project plan and budget.
  • Review designs for feasibility and accuracy.
  • Approve drawings and specifications.
  • Procure and evaluate prototypes.
  • Assist in the resolution of manufacturing- or quality-related issues.
  • Study and recommend improvements to existing packaging and processes or case systems. This entails staying "up to date" on emerging material and sterilization technologies. This may be accomplished by attending seminars, classes and industry meetings.
  • Perform package/case evaluations.
  • Identify, analyze and recommend new technologies or materials for specific applications.
  • Define and execute product testing and validation protocols.
  • Know and apply the Quality System and any appropriate Federal and International standards.

Skills Knowledge and Expertise
Education:
  • Bachelor's degree from an accredited institution required

Experience:
  • Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, statistics, basic packaging methods, packaging evaluation, packaging materials, and technical writing.

Functional/Technical Knowledge, Skills and Abilities Required:
  • Must have a practical working knowledge of medical-device packaging or sterilization case systems, packaging/case evaluation techniques/methods, engineering drawing interpretation, packaging/case manufacturing and inspection methods/processes, FDA/ISO requirements, project management, orthopedic implants and/or instruments and the materials and methods used in their packaging or sterilization cases.
  • Must have knowledge of various software packages including Microsoft Office applications. Knowledge of CAD applications is preferred.