Sr. Software Engineer (Medical Devices) Job at Bytecubit Technologies (Raleigh, NC)

Sr. Project Manager - Mobile App

The Sr. Project Manager – Mobile App will lead strategy, planning, and execution...

Location

United States , Burlington

Salary:

130000.00 - 140000.00 USD / Year

Myomo

Expiration Date

Until further notice

Requirements

Bachelor’s Degree required
degree in Engineering, Computer Science, or related technical field preferred
5+ years of project management experience with a focus on software or digital health products, ideally within the medical device or regulated industry
Proven experience in mobile app development and launch, including oversight of agile or hybrid software development processes
Experience working with cross-functional teams in a matrixed environment
Familiarity with FDA, ISO 13485, IEC 62304, and other medical software development standards
Strong organizational, communication, and problem-solving skills
Experience integrating hardware and software systems (e.g., Bluetooth-enabled medical devices)
PMP Certification preferred

Job Responsibility

Lead the development and launch of a mobile app that integrates with existing and next-generation Myomo orthotic devices
Manage all aspects of mobile software project planning and execution including schedules, risk management, milestones, and budgets
Collaborate cross-functionally with software engineering, hardware, regulatory, quality, marketing, and clinical teams to ensure product requirements and compliance needs are met
Drive execution through the phase gate process, ensuring adherence to design controls and software quality system requirements
Facilitate cross-departmental communication and ensure stakeholder alignment
Contribute to resource planning, project cost estimation, and forecasting in alignment with PMO and business priorities

Fulltime

New

Sr. Principal Engineer, PDO & Verification

Baxter’s Research and Development teams work cross functionally to innovate, dev...

Location

United States , Raleigh

Salary:

144000.00 - 216000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Electronics Engineering and Communications or related field plus 8 years of related experience
Translate Customer/end user needs, design constraints, and regulatory mandates into comprehensive system requirements, including functional, non functional, and performance specifications for medical devices and health software
Perform comprehensive risk evaluation in compliance with ISO 14971, ensuring identification, analysis, and control of medical device risks
Analyze system behavior for complex medical products under FDA guidelines in accordance with IEC 60601-1 and IEC 80601-1 standards
Lead the verification and validation of medical devices and health software in strict accordance with IEC 62304 and IEC 82304, ensuring traceability, regulatory compliance, and adherence to FDA recognized software development lifecycle standards
Develop and maintain comprehensive verification and validation plans for medical devices and health software, including detailed test protocols, execution records, and test reports, ensuring full traceability, regulatory compliance with FDA requirements, and alignment with engineering best practices and standards such as 21CFR-820
Perform integration and validation testing of Kubernetes based medical device monitoring platforms across On Prem and Cloud, leveraging Docker, Kubernetes, MQTT, and RabbitMQ with secure API driven communication to ensure interoperability and compliance in regulated healthcare environments
Create and maintain regulatory compliant technical artifacts—including development plans, test protocols, traceability matrices, and verification/validation reports—in alignment with FDA requirements and medical device industry standards such as IEC 62304 and ISO 13485
Plan and prepare the test environment for integration of medical devices with Electronic Medical Record (EMR) systems, ensuring interoperability, data integrity, and patient safety in compliance with FDA regulations, IEC 62304 software lifecycle requirements, and HL7/FHIR interoperability standards
Expertise in IHE Patient Care Device (PCD) Alarm Communication Management Profile, which uses HL7 messaging standards to communicate between medical devices and alert management systems

Job Responsibility

Design and develop medical device systems and digital platforms, ensuring compliance with regulatory and business standards from concept to commercialization
Create and maintain product and software architecture, user interface design, and specifications that meet customer needs and regulatory requirements
Utilize systems engineering and design thinking to define functional and performance requirements for products and systems
Model behaviors across systems and conduct risk analysis from a systems perspective
Perform risk management activities, including analysis, evaluation, and mitigation, in accordance with ISO 14971
Develop and maintain verification and validation plans, test protocols, and reports to comply with FDA and industry standards
Conduct integration and system validation testing for Kubernetes-based digital platforms in On-Prem and Cloud environments
Prepare technical documentation (design plans, traceability matrices, test reports) in compliance with FDA-approved quality processes for Class I/II and MDDS products
Train and mentor the systems team

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)
401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Sr Principal Engineer, Software

Unique and exciting opportunity to contribute to the design, development and sup...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Highly process oriented and demonstrated proficiency in various software development lifecycle methodologies including Agile, Iterative, V-Model, etc.
Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971
Must have several participated in several projects which lead to successful product introduction in the marketplace and at least some of them had significant positive business impact
Deep and broad understanding of many technological areas: Analysis and Design: Object oriented architecture, Design Patterns, UML
Systems Engineering: Requirements engineering, use-case development, story boarding and JAD sessions, wire-framing, software risk assessment
Programming and Framework Server: PHP, Laravel, .net Core, C#
Programming and Framework Client: HTML5, JavaScript, JQuery,Vue.JS
Enterprise Integration: Design patterns for enterprise integration, SOA, SOAP/REST, Microservices, RabbitMQ etc.
Development and Continuous Integration: Visual Studio, VS Code,BitBucket, SVN, Git, JIRA, Fisheye, Sonar, Clover, etc.
Database and BI: MySQL , PostgreSQL Tableau, Power BI, etc.

Job Responsibility

Responsible for providing leadership within assigned team to ensure key metrics for projects and/or sprints are met
Develops a solid architecture that balances requirements from multiple stakeholders including marketing/product owner, program management, operations, quality assurance and service
Must ensure that architecture allows meeting time-to-market, exceeding quality targets, quick diagnosis of problems in the field, quick diagnosis of issues during product development and requirements evolution (scalable / extensible)
Responsible for creating design artifacts based on requirements/use-cases and software architecture
Responsible for implementing modules/units, performing peer code review, performing unit-testing, subsystem testing and participating/leading various system integration activities
When applicable leads creation of software requirements based on understanding of deep customer needs and hosts JAD (Joint Application Design) sessions. Responsible for reviewing and supporting creation of defect free requirements/use-cases
Responsible for creating user interface design based on current best practices for web based and mobile customer facing applications
When applicable responsible for providing design/technical specifications to external design partners
Responsible for rapid prototyping of highly innovative concepts for concept/feasibility testing.

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Sr Principal Engineer, Software

Unique and exciting opportunity to contribute to the design, development and sup...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Highly process oriented and demonstrated proficiency in various software development lifecycle methodologies including Agile, Iterative, V-Model, etc.
Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971
Must have several participated in several projects which lead to successful product introduction in the marketplace and at least some of them had significant positive business impact
Deep and broad understanding of many technological areas: Analysis and Design: Object oriented architecture, Design Patterns, UML
Systems Engineering: Requirements engineering, use-case development, story boarding and JAD sessions, wire-framing, software risk assessment
Programming and Framework Server: PHP, Laravel, .net Core, C#
Programming and Framework Client: HTML5, JavaScript, JQuery,Vue.JS
Enterprise Integration: Design patterns for enterprise integration, SOA, SOAP/REST, Microservices, RabbitMQ etc.
Development and Continuous Integration: Visual Studio, VS Code,BitBucket, SVN, Git, JIRA, Fisheye, Sonar, Clover, etc.
Database and BI: MySQL , PostgreSQL Tableau, Power BI, etc.

Job Responsibility

Responsible for providing leadership within assigned team to ensure key metrics for projects and/or sprints are met
Develops a solid architecture that balances requirements from multiple stakeholders including marketing/product owner, program management, operations, quality assurance and service
Must ensure that architecture allows meeting time-to-market, exceeding quality targets, quick diagnosis of problems in the field, quick diagnosis of issues during product development and requirements evolution (scalable / extensible)
Responsible for creating design artifacts based on requirements/use-cases and software architecture
Responsible for implementing modules/units, performing peer code review, performing unit-testing, subsystem testing and participating/leading various system integration activities
When applicable leads creation of software requirements based on understanding of deep customer needs and hosts JAD (Joint Application Design) sessions. Responsible for reviewing and supporting creation of defect free requirements/use-cases
Responsible for creating user interface design based on current best practices for web based and mobile customer facing applications
When applicable responsible for providing design/technical specifications to external design partners
Responsible for rapid prototyping of highly innovative concepts for concept/feasibility testing

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Sr Eng, System Verification

As System Verification and Validation (V&V) Sr.Engineer for Infusion pumps team ...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Bio-Medical, Industrial Engineering or related field
Overall 6 to 10 yrs of experience with minimum 3 years in System Verification testing and performance testing
Hands on experience in overall final design verification/validation(V&V) testing of medical products
Relevant technical testing/reliability experience in electro-mechanical, electrical testing of Medical Devices
An understanding of test methods and processes as well as the methods used to verify product in the realms of
mechanical, electrical, functional testing environments
Basic hands on experience in data analysis of Performance testing and Sample size calculations for variable/Attribute data
Experience in Tools like Minitab( Data Analysis) / JIRA ( Defect ) / ALM ( test Environment) etc.
Understanding of hardware and software product design methodologies and test practices
Experience in medical device or similar product development, design verification/validation, system integration (hardware/Subsystem/Software), risk management, reliability engineering, process validation and Quality systems

Job Responsibility

Lead/Execute, perform, summarize, and report out System verification test activities Medical devices
Understand URS (User requirements) / System Requirements and prepare the System Level Test cases and Prepare test procedures
Understand the product functionality and perform the Functional and Performance testing for the product
Lead/Support and perform Design Verification activites
Drive/Perform Installation/Operational/Performance Qualification Protocols
Prepare Traceability Matrices and Final Reports
Lead compliance/ closure of Regulatory and Quality requirements
Develop Test instructions and Test protocols
Follow instructions clearly from Design engineers during Test execution
Support Design engineers in Test fixture creation, building up & tearing down Test equipment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

IT Sr Software Engineer- BMDI

The Epic Software Engineer will be a self-motivated leader within a team of smar...

Location

United States , Englewood

Salary:

49.78 - 74.05 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Strong Communicator and competence in both Clinical and technical subject matter delivery
Robust organizational skills in verbal & written form, including presentations, report generation and accurate documentation
Previous experience working with medical device EHR interfaces and performing the analysis of the clinical or ancillary department processes, workflows, and data requirements
Experience with interface and data integration concepts that include common medical device integration communication standards and / or other industry-standard data exchange protocols such as HL7
Medical Device / System configuration and / or administration experience.
Experience with application support, troubleshooting and creating operational support guidelines
Vendor engagement experience for generating data, design, analysis, and testing requirements
Experience with application and system integration validation and verification testing including unit, functional, integration, regression, and high-risk scenario testing
Knowledge of integration and interoperability trends and professional practice recommendations
Generate and / or contribute to whitepapers and/or reports pertaining to medical device integration efforts

Job Responsibility

Responsible for the analysis, implementation and support of middleware interfaces between Biomedical devices (Anesthesia machines, Physiological Monitors, Cardiac Output, BIS, Mechanical Ventilators, BIPAP/CPAP, Hemodialysis, CRRT, Perfusion & Physiological Patient Monitor Gateway), an interface engine (if applicable) and the Epic application.
Provides secondary and tertiary support for day-to-day production issues and maintains documentation in the appropriate tracking systems.
Works to prescribed methodologies for all project implementations.
Provides subject matter expert leadership for serial output and real-time HL7 interfaces
coordinates modifications
identifies issues and their resolutions
and tests to make certain the data exchanges are correctly formed (including software upgrades, patching, but not limited to).
Facilitates project meetings and dashboard status updates.
Analyzes and translates business requirements into interface requirements.
Maintains an expertise in Epic technology, applications and processes related to the support of real-time, HL7.

What we offer

medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Sr. iOS Engineer

Dawn Health is a leading Digital Health product company that empowers Life Scien...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Have min. 5 years of experience working within the iOS ecosystem (Xcode, Swift, iOS SDK)
Ability to adapt and implement solutions in different architectural patterns like MVC and MVVM
Deep understanding of the SOLID principles
Desire to implement state-of-the-art UX and a willingness to challenge the designs and be able to referee to Apples Human Interface Guidelines
Ability and motivation to document System Designs, Architecture, Configurations on various levels of detail
Experience with git and git flows
Professional proficiency in English

Job Responsibility

Build state of the art iOS Apps based on a modern tech stack
Work in close collaboration with the product and development team using agile workflows and best practices
Support our Business Development team with technical input and project estimations
Support our Project Managers in writing project specs and technical insight
Engage with continuous delivery workflows in rapid development cycles
Build and document architectures that are certified Medical Device software

What we offer

A chance to work alongside innovative colleagues that are great at what they do and are happy to share knowledge
An open, informal, and friendly atmosphere, which we are proud of and nourish
A broad range of meaningful projects and own products that need your valued input
Autonomy, self-leadership, and confidence in you and your abilities
Celebration of our wins and social events on a regular basis to meet and get to know all our colleagues
An array of benefits within the areas of culture, professional development, and a competitive health package
The possibility to leave your mark on digital health

Fulltime

Product Owner – Sr Principal Software Systems Engineer for Digital Applications

Join our dynamic team as a Product Owner – Sr Principal Software Systems Enginee...

Location

United States , Raleigh

Salary:

128000.00 - 176000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Product Manager/Product Owner experience demonstrating strong customer focus and direct interactions with customers - preferably within regulated connected medical devices/cloud applications space
Experience being at customer sites regularly and having connections with hospitals/caregivers/clinical customers
Experience working with marketing/sales/commercial teams
Expertise in product backlog creation and management, requirements management, risk management, and development in an Agile environment (e.g. milestones/sprints)
Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
Experience with SaMD classified and MDDS digital/cloud applications preferred
Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus.
Exceptional oral and written communication skills.
Strong documentation skills and experience in a regulated industry.
A Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience.

Job Responsibility

Acquire and detail key customer needs/use insights through strong observation skills and communication skills
Collaborate with marketing, sales, and commercial departments to identify user needs that can be validated
Translate customer insights into product features working collaboratively with marketing
Work with remotely distributed teams to explain/drive product backlog and related epics to development and verification teams
Create and own product portfolio backlogs across multiple Digital Applications, using innovative methodologies
Work closely and guide individual Digital Application product owners within the portfolio to execute the product roadmap
Take prototypes of minimally viable product (MVP) to customers and get early feedback on digital product concepts and features
Work collaboratively with technical program managers assigned to product portfolios to ensure product backlog items and related epics are effectively groomed into the development cycles
Driving Guidelines: Implement and champion guidelines in software systems development and product lifecycles, applying Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with engineering and validation groups.
Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.

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)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Sr. Software Engineer (Medical Devices)

Bytecubit Technologies

Location:
United States , Raleigh, NC

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 06, 2025

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