System Engineer – Software as a Medical Device Job at 3Shape (Copenhagen)

Senior Medical Device Software Engineer

Join a mission-driven technology team that’s redefining what’s possible in cardi...

Location

United States , Greater Boston area

Salary:

Not provided

Intellias

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or related field with 4+ years of relevant experience OR Master’s degree with 2+ years of experience OR PhD with industry or research experience in relevant areas
Advanced proficiency in Python and C++
Strong knowledge of object-oriented design, data structures, and algorithms
Experience in real-time or embedded software development
Familiarity with network communication protocols and hardware–software integration
Experience in implementation Bluetooth stack, maintenance and configuration.
Hands-on experience with ROS, Linux-based development, and/or real-time operating systems
Experience with CI/CD pipelines, Git, and Agile development methodologies
Knowledge of cloud services (AWS or Azure) and scalable software architectures
Excellent communication and collaboration skills within cross-functional teams

Job Responsibility

Lead the design, development, and optimization of high-performance system software
Develop, test, and debug applications that interface directly with embedded and hardware components
Collaborate with multidisciplinary teams—hardware engineers, system architects, product managers, and QA—to define requirements and deliver solutions that meet clinical and regulatory standards
Drive code quality through peer reviews, automated testing, and continuous integration
Mentor junior engineers and promote engineering excellence through knowledge sharing
Document design decisions, development processes, and testing methodologies to ensure traceability and consistency
Troubleshoot complex software issues and deliver timely resolutions in a regulated environment
Participate in lab evaluations, pre-clinical testing, and system demonstrations for stakeholders and clinicians
Stay current on emerging tools, frameworks, and industry best practices to continuously enhance product performance and maintain technical leadership

Fulltime

Senior Security Engineer – Medical Device Cybersecurity & Compliance

Job Description: Senior Security Engineer – Medical Device Cybersecurity & Compl...

Location

India , Ahmedabad

Salary:

Not provided

Arrow Electronics

Expiration Date

Until further notice

Requirements

Minimum of 6 years of experience in cybersecurity
At least 3 years focused on medical devices, embedded systems, or IoT security
Proven track record in authoring security design, defining technical requirements, and documenting security architectures aligned with regulatory needs
Hands-on experience in embedded system security including secure boot, firmware security, threat modeling techniques (e.g., STRIDE, DREAD), and product-level risk assessments
Strong understanding of IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97
Working knowledge of the medical device product development lifecycle and quality standards like ISO 14971
Demonstrated expertise in vulnerability management and penetration testing of connected products across device and cloud ecosystems
Excellent problem-solving skills, critical thinking, and ability to lead gap analysis and remediation activities in regulated environments
Strong collaboration skills with the ability to influence cross-functional teams including R&D, compliance, and product management

Job Responsibility

Drive end-to-end cybersecurity integration across the medical device product development life cycle
Develop and maintain cybersecurity for medical products, including security requirements specifications, risk assessments, threat models, and product security architecture documentation
Conduct thorough gap assessments to evaluate compliance with IEC 81001-5-1, IEC 60601-4-5, AAMI TIR 57, and AAMI TIR 97 standards, and implement remediation measures
Perform hands-on vulnerability assessments, penetration testing, and secure code reviews of embedded devices, IoMT components, and connected systems
Collaborate closely with development, compliance, and regulatory teams to ensure product security measures meet both internal security policies and external regulatory expectations
Support SBOM management, software supply chain risk evaluations, and third-party component analysis
Provide expert input on secure communication protocols, encryption standards, data protection for both at-rest and in-transit data, and cloud-based connectivity of medical systems
Assist in developing incident response strategies
Contribute to the continuous enhancement of internal secure development processes, tools, and methodologies, while championing security best practices within product teams

Fulltime

ML Software Engineer – Medical Devices

We are looking for a Python Software Engineer to join our technology team and co...

Location

Spain , Valencia; Madrid; Barcelona

Salary:

Not provided

Quibim

Expiration Date

Until further notice

Requirements

Strong experience with Python (must)
Experience with containerization, especially Docker and Docker Compose (must)
Background in medical device software or other regulated software environments (strong plus)
Knowledge of DICOM and medical imaging workflows (strong plus)
Familiarity with CI/CD pipelines, static code analysis, and automated testing
Working knowledge of C++ (reading, debugging, or extending existing code)
Understanding of software architecture principles (design drivers, patterns, APIs, modularity, distributed systems)
Familiarity with AI/ML Python frameworks such as TensorFlow or PyTorch, primarily from an integration and usage perspective
Comfortable working in Linux environments
Solid experience using Git

Job Responsibility

Design, develop, and maintain Python-based software for medical devices and supporting systems.
Contribute to device software and system-level components such as integration and connectivity services, orchestration layers, and supporting tools.
Work with medical imaging standards (especially DICOM).
Participate in software architecture discussions, contributing to modular, scalable, and maintainable designs.
Collaborate with QARA, system engineering, and product teams throughout the development lifecycle.
Write technical documentation, and support verification and validation activities.
Develop, test, and deploy applications on Linux-based platforms.

Fulltime

Sr. Software Engineer (Medical Devices)

Location

United States , Raleigh, NC

Salary:

Not provided

Bytecubit Technologies

Expiration Date

Until further notice

Requirements

7+ years’ experience with SW development
SW development for Medical Devices
BS in Computer Science
C, C#, C++ skills
Microsoft.NET
SQL database
GUI application development
Windows 10
Cryptographic algorithm

Job Responsibility

Consultant will be responsible for design and development of embedded SW for medical device to support manufacturing of products
write SW requirements
provide design input for GUI system SW
design development and implementation of cybersecurity control methods for FDA NIST standards
testing, static analysis, profiling and debugging
take measurements using lab equipment tools
data processing for test protocols

Senior Software Engineer - Robotic Applications

Location

Germany , Munich

Salary:

Not provided

Brainlab

Expiration Date

Until further notice

Requirements

A degree in Computer Science, Medical Engineering, Robotics, Physics, Engineering or a related discipline, or equivalent working experience
Strong problem-solving skills and experience in software design and implementation, with a strong focus on code quality, maintainability and testing
Solid experience in C++ and experience with TypeScript/HTML5 or modern GUI development is plus
Experience with medical device software, system integration or interoperability standards such as DICOM and FHIR is a plus
Knowledge of networking, test automation, embedded systems or robotics is beneficial
Basic knowledge of working with version control systems (Git, GitLab/GitHub)
You want to be part of a high-skilled team and make a difference with your code every day
Fluent English, eagerness to learn German and ability to communicate with colleagues from all around the world and different areas of specialty complete your profile

Job Responsibility

Design, implement and test application software that integrates a robotic arm into clinical workflows on Brainlab navigation platforms
Develop product features across the application stack, including C++ backend components, user-facing GUI functionality and robotics algorithms
Translate clinical and user workflow requirements into robust, intuitive and safe software solutions for surgeons and clinical staff
Work on the integration of the robotic system into a larger medical device ecosystem, including communication with other software and medical devices
Contribute to interoperability topics such as DICOM, FHIR and network-based system integration
Be involved in the development process from the very first idea until the final product launch
Analyze risks, document and verify the development in a regulated medical device environment
Work closely with your international colleagues from different teams and disciplines

What we offer

A mutually-supportive, international team
Meaningful work with a lasting impact on medical technology
30 vacation days, plus December 24th and December 31st
Bike leasing via cooperation partner "BikeLeasing"
Parking garage and safe underground bike storage
Award-winning subsidized company restaurant and in-house cafes
Variety-rich fitness program in our ultra-modern 360m2 company gym
Regular after work, team, and company events
Comprehensive training and continuing education opportunities

Fulltime

Principal Software Engineer, Android

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

United States , Milwaukee

Salary:

112000.00 - 154000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s/Master’s degree in Computer Science or related field with 5+ years in software engineering and 2+ years developing Android applications
Proficiency in Java/Kotlin, with additional familiarity in JavaScript/TypeScript and C++ for embedded/firmware
Hands‑on experience with Android SDK, NDK, Android Studio, and strong understanding of Android architecture, components, security, and best practices
Background in regulated industries preferred, especially medical devices with exposure to IEC 62304 and quality/regulatory collaboration
Strong software architecture, design patterns, SOLID principles, TDD, and CI/CD familiarity
Experience working in Agile environments using tools like Azure DevOps or Jira, and version control systems such as Git or SVN
Proven track record of delivering technical solutions, solving complex problems, and working effectively with cross‑functional and multisite teams
Excellent communication, leadership, and collaboration skills, with a proactive mindset and willingness to mentor and drive team success

Job Responsibility

Apply and demonstrate strong software engineering expertise to build and develop robust software architectures
Influence the processes and methodologies the team uses to develop quality software
Develop software components in an Android environment that will be deployed in medical products, using architectural patterns, strong object-oriented principles, unit testing, and automated testing tools
Own and control software implementation, ensuring that software is built in a modular fashion, testable, reusable, and maintainable
Participate in the formal documentation processes for requirements generation, software architecture, and detailed builds
Analyze and understand product requirements, deriving software requirements
Identify key product-level technical risks and assist project managers in developing mitigation and recovery plans
Review work products and ensure the quality of deliverables
Provide input to test strategies at both product and module levels
Drive the application of principles of SDLC and methodologies like Lean/Agile/XP, Software and Product Security, Scalability, Documentation Practices, refactoring, and testing techniques

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Technical Specialist (Staff) Software Engineer- QT Framework

This is where new knowledge is discovered. Baxter's Research and Development tea...

Location

United States , Raleigh

Salary:

168000.00 - 231000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Software Engineering, or a related field
10+ years of software development experience, with a strong focus on embedded systems and Qt Studio or similar UI SDKs
Hands-on experience building and maintaining Jenkins CI/CD pipelines, including job configuration and troubleshooting
5+ years of software development and validation experience within a regulated industry
Strong working knowledge of IEC 62304, IEC 60601, ISO 14971, and familiarity with FDA 21 CFR Part 820 and EU MDR preferred
Proven ability to enforce rigorous software development, verification, and validation documentation standards
Experience working in Agile development environments, supporting adaptive and collaborative delivery
Effective communicator with a servant leadership mindset, able to translate technical concepts for non-technical stakeholders and mentor teams

Job Responsibility

Lead UI software architecture design for medical devices using Qt Studio
Collaborate cross-functionally to define requirements, create test cases, and ensure specifications are met
Mentor junior engineers and promote best practices, learning, and innovation
Design scalable Qt applications using Qt Widgets and MVC/MVVM architectural patterns
Develop and execute automated tests using Qt Squish and ensure IEC 62304/FDA compliance with QA teams
Build and maintain embedded software platforms in C/C++, integrating closely with hardware components
Drive software quality through design reviews, secure coding practices, and performance optimization
Maintain clear architecture documentation and manage source code using Git

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Software Engineer, NorthStar

We are seeking a Senior Software Engineer who is comfortable operating at the in...

Location

United States , Burnsville

Salary:

110000.00 - 140000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

5+ years of software engineering experience
Experience in regulated environments (e.g., medical devices)
Strong proficiency in one or more of: C#, Python, Javascript, Bablylon
Experience working on complex, integrated systems
Strong debugging and problem-solving skills
Ability to translate technical implementations into clear documentation
Comfortable owning both code and documentation responsibilities
Strong communication skills and ability to work cross-functionally

Job Responsibility

Designs, implements, and supports software features across NorthStar and related systems
Translates features and system behavior into clear, testable software requirements
Contributes to and maintains software design documentation (SDS, SAD)
Supports development of verification artifacts, including DVT plans and traceability
Participates in risk management activities (e.g., hazard analysis, FMEA)
Ensures alignment between implementation, requirements, and verification
Partners with QA and cross-functional teams to support release readiness
Helps identify gaps in current documentation and drive improvements
Educates and guides other engineers on writing effective requirements, maintaining traceability, and contributing to compliant documentation practices
Participates in code reviews, design discussions, and debugging complex system issues

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

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System Engineer – Software as a Medical Device

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