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Medical Device Embedded Software Engineer information

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 Georgia?

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

What job categories do people searching Medical Device Embedded Software Engineer jobs in Georgia look for?

The top searched job categories for Medical Device Embedded Software Engineer jobs in Georgia are:

What cities in Georgia are hiring for Medical Device Embedded Software Engineer jobs?

Cities in Georgia with the most Medical Device Embedded Software Engineer job openings:

Medical Device Embedded Software Engineer jobs near you

Embedded Developer

Sonoma Consulting Inc.

Alpharetta, GA • On-site

Full-time

Re-posted 27 days ago

Job description

Company Description

Sonoma Consulting is one of the fastest growing national IT Consulting and Executive Search company in the United States, which was founded in 2011 by Mark McGee, the President and CEO. Sonoma Consulting has two business divisions - IT Consulting Services & Executive Search to serve its 150 national clients which range from entrepreneurial start-ups to Global Fortune 500.

Job Description

Position: Embedded Developer- Medical Device

Location: Alpharetta, GA

Duration: Direct Hire (Fulltime Permanent)

Come join a fast growing billion dollar medical device and products company that provides innovative products entero-medical and pain devices! Position located in.

As a Medical Device Engineer you will be working with cross-functional teams to drive and grow technical capabilities of the R&D organization. This is a hands-on medical device software engineer with strong skills creation and building of flawless code.

Implement software designs for isolation of critical path or safety critical design elements

Review complex software design concepts prior to implementation

Participate in the integration of software implementations with system interfaces

Approve supporting documentation in order to secure project release

Anticipate project challenges and risk scenarios

Identify and execute proactive mitigation strategies to ensure optimal results

Support project management, including software development, scope, and release planning

Participate in the execution, documentation, review, and approval of all processes in SDLC

Qualifications & Skills:

B.S. in Software Engineering, BioMed, Computer & Electrical Engineering, Computer Science or related field

7-9+ years' experience required within FDA regulated medical device industry

Proven software engineering disciplines with working knowledge of cGMPs and applicable industry standards

Thorough understanding of the SDLC

Experience integrating software and hardware in an embedded context

Experience reviewing, porting, and integrating third-party code, and using application frameworks

Intensive experience in micro-controller programming, preferably using 8051 & AVR RISC architectures

Familiarity with standard OS features (e.g. threading and concurrency, memory management, device drivers, I/O, etc.

Strong C/C++ programming skills

Working experience with embedded RTOS preferred

Intensive familiarity with QNX or UNIX/Linux preferred

Experience in GUI application design

Experience in algorithm development, mathematical transformations, and protocol formulation preferred

Design Control, Risk Analysis, Change Control, and problem solving (CAPA)

Experience presenting concepts for different levels of organization fr executives to software developers

Proven track record of software development effectiveness; leadership preferred

Qualifications

Skills: Embedded, C/C++, RTOS, FDA, Medical Device, Embedded Developer / Embedded Engineer / Sr. Embedded Developer / Sr. Embedded Engineer / Embedded C++ Developer / Embedded C++ Engineer / Embedded C++ Programmer 

Title: Embedded Developer / Embedded Engineer / Sr. Embedded Developer / Sr. Embedded Engineer / Embedded C++ Developer / Embedded C++ Engineer / Embedded C++ Programmer 

Search Words: Embedded Developer / Embedded Engineer / Sr. Embedded Developer / Sr. Embedded Engineer / Embedded C++ Developer / Embedded C++ Engineer / Embedded C++ Programmer 

Additional Information

Skills: Embedded, C/C++, RTOS, FDA, Medical Device

Title: Embedded Developer / Embedded Engineer / Sr. Embedded Developer / Sr. Embedded Engineer / Embedded C++ Developer / Embedded C++ Engineer / Embedded C++ Programmer 

Search Words: Embedded Developer / Embedded Engineer / Sr. Embedded Developer / Sr. Embedded Engineer / Embedded C++ Developer / Embedded C++ Engineer / Embedded C++ Programmer 

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About Sonoma Consult

Sourced by ZipRecruiter

Sonoma Consult is a California based C corporation helping companies bring products to the patient by working closely with the engineering teams and the clinicians. Our goal, no matter what stage of product development, is to create and execute a plan of action to move the product through the appropriate clinical and regulatory steps. Sonoma Consult works cohesively with the engineers and physicians to translate technologies to the clinic. Our goal is to help you get the very best product to the clinic and to the market. This includes planning, execution and ensuring critical data is delivered in the right format to ensure the feedback loop to the design team ultimately delivers the most advanced technology to the patient.

Industry

Business management consulting

Company size

1 - 10 Employees

Headquarters location

Sonoma, CA, US

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