Department:    R&D

Reports to:      Sr. VP, R&D

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Software Engineer, Principal (Test) will design and implement testing strategies for our 3D cardiac mapping system while remaining hands-on with verification and validation activities. You will play a critical role in ensuring the safety, performance, and reliability of our products through rigorous system-level testing and cross-functional collaboration.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Designs and leads execution of verification and validation test plans, with a focus on complex, high risk, or system level test scenarios, including functional, performance, and stress testing.
• Establish and uphold principles for scalable test design, including test case structure, traceability, and regulatory submission readiness.
• Ensure test strategies address clinical workflows and hardware/software/algorithm integration challenges.
• Collaborate closely with software, algorithms, and hardware teams to perform root-cause investigations for complex, ambiguous, or cross-functional issues.
• Contribute to automation efforts by partnering with team members, guiding framework architecture decisions, and implementing automated tests to support long-term scalability.
• Mentor team members and set a high technical bar for test design, investigations, risk analysis, and documentation quality.
• Author and review test plans, protocols, trace matrices, and reports to ensure alignment with medical standards and regulatory expectations.
• Influence key requirements, design, and architecture discussions to ensure testability and alignment with test strategies.
• Continuously evaluate and adopt test setups, tools, and methodologies to improve testing effectiveness, efficiency, and maintainability.
• Support inspection readiness and regulatory activities including submission documentation and audits.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• 11+ years of hands-on experience as either a software test engineer, validation engineer, or in a similar role, with a preferred focus on software validation.
• Minimum of a Bachelor’s degree in a scientific/engineering discipline, or equivalent combination of education and experience. Computer science or electrical engineering degrees are preferred.
• Demonstrated contributions to 510(k) submissions, audits, or regulatory deliverables, including preparation or review of test documentation.
• In-depth familiarity with IEC 62304 and software verification and validation processes for medical device software.
• Track record of designing scalable, risk-based test strategies and producing high-quality documentation.
• Proven experience in testing complex, integrated systems involving software, hardware, and algorithms.
• Strong troubleshooting, analytical thinking, and debugging skills in multidisciplinary environments.
• Experience with test automation tools/frameworks and scripting languages (e.g., Python, C++, etc.)
• Strong working knowledge of test management tools such as Jira, TestRail, ADO, or similar platforms.
• Experience collaborating effectively in Agile development environments.
• Excellent verbal and written communication skills for cross-functional influence, mentoring, and high-quality documentation.
• Ability to manage a significant technical workload, prioritize effectively, and operate with a high degree of autonomy.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted. 

Department:    R&D, Systems Engineering

Reports to:      Director, Systems Engineering               

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system, integrated NanoAblate™ PFA platform, and a comprehensive set of mapping and ablation catheters. Driven by our global mission to enhance the quality-of-life of heart rhythm patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The System Engineer, Senior Staff (Systems & Catheters) will perform and lead design control activities, including design verification and validation (V&V) and design transfer, for cardiac mapping and ablation systems and catheters. The role is responsible for creating mechanical drawings, authoring documentation, and executing internal design control activities for systems and catheters. This position will also support IEC safety testing at third-party test houses and contribute to the submission and release of QMS documentation. In addition, the role has responsibility for the development of next-generation systems and catheters.

Duties and Responsibilities   

The following are the major responsibilities for this role. Additional responsibilities, tasks, and duties may be required and will be assigned as needed.

• Lead and perform the system and catheter design control, design V&V activities for 3D cardiac mapping and ablation systems as well as catheters.
• Create mechanical drawings and maintain the design history files for the system and catheters.
• Create system and catheter design control documentation.
• Develop the system and catheter design V&V protocols and test methods and release them in the QMS.
• Execute and/or provide guidance for execution of V&V Protocols and author Test Reports for FDA submission.
• Perform system and catheter test, signal processing and data analysis for troubleshooting issues and finding solutions to improve system performance.
• Ensure compliance with QMS procedures and regulatory standards.
• Perform IEC 60601 safety testing at 3rd party test houses to support regulatory submission.
• Collaborate with teams to design, develop, and test next-generation systems.
• Conduct or participate in design reviews for the system and catheter design.  

Experience, Education and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• 8-12 years of related technical experience and A Bachelor’s and/or master’s degree in engineering, and/or other technical disciplines.
• Experience in regulated medical devices industries and good understanding of IEC 60601 standards is required.
• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.
• Solid skills for system testing, system V&V and authoring QMS documentation are required.
• Experience with Cardiac Ablation catheters and/or electrophysiology mapping system is a plus.
• Solid skills in Mechanical design using SolidWorks or similar software tools.
• Exceptional problem-solving skills and analytic thinking to overcome technical challenges.
• Outstanding communication and interpersonal skills, with the ability to collaborate seamlessly with internal teams and external partners.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted. 

Department:    Quality

Reports to:      Quality, Senior Manager               

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Quality Engineer, Staff (Software) will play a hands on, high impact role in executing design controls remediation for capital system medical devices, operating within established quality system governance and strategic direction. This role is execution focused and operates under the direction of Quality leadership, with responsibility for translating defined quality strategy, policies, and regulatory expectations into complete, auditable design control deliverables.  The initial focus of this role will be to assess existing development artifacts, structure a compliant Design History File (DHF), and partner closely with R&D to prepare the organization for FDA and EU MDR submissions.

This role is ideal for an experienced quality professional who thrives in ambiguity, enjoys building compliant systems from imperfect starting points, and is comfortable rolling up their sleeves to support FDA and EU MDR submission readiness. You will collaborate closely with software, systems, hardware, clinical, and regulatory partners while helping to shape a scalable quality culture aligned with both regulatory expectations and startup realities.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Lead execution of software design controls remediation, including:
  • Defining and structuring the Design History File (DHF)
  • Identifying and closing documentation gaps
  • Aligning reviews, approvals, and traceability
• Partner closely with software and R&D teams to translate existing development outputs (e.g., architecture, requirements, test artifacts) into compliant:
  • Design Inputs and Design Outputs
  • Verification and Validation evidence
  • Traceability matrices
• Identify risks and prioritize critical documentation to meet regulatory timelines and commitments
• Support FDA and EU MDR submission readiness, including preparation of objective evidence, audit trails, and regulator facing documentation.
• Support FDA inspections and external audits, including internal readiness activities and direct participation.
• Review and contribute to risk management activities, including hazard analysis, Software FMEA, and linkage to design and process controls.
• Apply defined software quality expectations aligned with:
  • IEC 62304 - Medical Device Software Lifecycle Processes
  • IEC 62366 - Usability Engineering
  • FDA software and cybersecurity guidance
• Act as a quality execution partner to engineering teams, reinforcing consistent application of established design controls and risk management practices.
• Escalate gaps, risks, and systemic issues to Quality leadership with clear, evidence‑based recommendations.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• Bachelor’s degree in Engineering, Computer Science, or a related technical field.
• 5+ years of Software Quality Engineering experience within the medical device industry.
• Demonstrated independent, hands on experience remediating software design documentation, including DHF restructuring.
• Direct experience supporting software new product development.
• Experience supporting FDA submissions (IDE, 510(k), or PMA) or regulatory inspections.
• Strong working knowledge of:
  • FDA Design Controls (21 CFR 820.30 / QMSR alignment)
  • Software development lifecycle documentation
  • Risk management and traceability
  • IEC 62304, including software safety classification and lifecycle documentation
  • IEC 62366, including user interface and usability considerations
  • FDA Software Validation guidance

Preferred Skills and Attributes:

• Working knowledge and practical application of:
• Comfortable operating in fast paced, evolving environments
• Strong communicator able to bridge engineering execution and regulatory expectations
• Highly organized, self directed, and adaptable to shifting priorities

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted. 

Department:    Quality

Reports to:      Quality, Senior Manager               

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes. 

Position Overview

The Quality Engineer, Staff (Hardware) will play a hands on, high impact role in executing design controls remediation for catheter based medical devices, operating within established quality system governance and strategic direction. This role is execution focused and operates under the direction of Quality leadership, with responsibility for translating defined quality strategy, policies, and regulatory expectations into complete, auditable design control deliverables.  The initial focus of this role will be to assess existing development artifacts, structure a compliant Design History File (DHF), and partner closely with R&D to prepare the organization for FDA and EU MDR submissions.

This role is ideal for an experienced quality professional who thrives in ambiguity, enjoys building compliant systems from imperfect starting points, and is comfortable rolling up their sleeves to support FDA and EU MDR submission readiness. You will collaborate closely with catheter design, process development, manufacturing, clinical, and regulatory partners while reinforcing a scalable quality culture aligned with both regulatory expectations and startup realities.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Lead design controls remediation for catheter and hardware systems, including:
  • Defining and structuring the Design History File (DHF)
  • Identifying and closing documentation gaps
  • Aligning design reviews, approvals, and traceability
• Partner closely with R&D, catheter design, and process development teams to translate existing development outputs (e.g., drawings, specifications, test methods, prototypes) into compliant:
  • Design Inputs and Design Outputs
  • Verification and Validation (V&V) evidence
  • Traceability matrices
• Identify risks and prioritize critical documentation to meet regulatory timelines and commitments
• Support FDA and EU MDR readiness, including preparation of objective evidence, audit trails, and regulator facing documentation.
• Support FDA inspections and external audits, including internal readiness activities and direct participation.
• Review and contribute to risk management activities, including hazard analysis, FMEA, and linkage to design and process controls.
• Apply defined hardware and device quality expectations aligned with:
  • FDA Design Controls and QMSR expectations
  • ISO 13485
  • ISO 14971 risk management principles
• Act as a quality execution partner to engineering teams, reinforcing consistent application of established design controls and risk management practices.
• Support transfer activities as designs mature toward manufacturing readiness.
• Escalate gaps, risks, and systemic issues to Quality leadership with clear, evidence‑based recommendations.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, or related technical discipline)
• 5+ years of Quality Engineering experience within the medical device industry
• Demonstrated independent, hands on experience with design documentation remediation, including DHF restructuring
• Direct experience supporting catheter based or disposable medical device development
• Experience supporting FDA submissions (IDE, 510(k), or PMA) or regulatory inspections
• Strong working knowledge of:
  • FDA Design Controls (21 CFR 820.30 / QMSR alignment)
  • Hardware and process development lifecycle documentation
  • Risk management and design traceability

Preferred Skills and Attributes:

• Experience with supporting catheter design and development, manufacturing processes, and testing, such as:
• Working knowledge and practical application of:
  • ISO 14971 risk management
  • Design verification and validation for invasive devices
  • FDA guidance for intravascular or catheter-based devices
• Comfortable operating in fast paced, evolving environments.
• Strong communicator able to bridge hands on engineering execution and regulatory expectations.
• Highly organized, self-directed, and adaptable to shifting priorities.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted.

Department:    R&D – Hardware Engineering

Reports to:      Director, Hardware Engineering              

Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Hardware Engineer, Staff (Test) is responsible for the design, validation, and system integration of complex hardware subsystems for electrophysiology (EP) platforms, including mapping and ablation systems. This role ensures hardware performance, signal fidelity, and patient safety while driving verification strategies and regulatory compliance.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Design and development of automated board-level and system-level hardware test fixtures (functional test, bed-of-nails, HIL systems) for complex PCBAs
• Perform validation (IQ, OQ, PQ) of test hardware, test software, and test methodologies.  
• Strong experience with Design for Testability (DFT) and Design for Manufacturability (DFM)
• Be for voice for Manufacturing in design phase to ensure final hardware design is testable.
• Ability to define test architectures for high-channel-count acquisition system for electrophysiology and pulse-field ablation system
• Participate in the design and development of complex analog front-end, data acquisition, and isolation circuits for patient-connected medical systems.
• Support hardware architecture definition and lead cross-functional tradeoff analysis across performance, safety, manufacturability, and cost.
• During verification and validation phase, execute comprehensive hardware V&V strategies, including test protocol development, test execution, and reporting.
• Lead root cause analysis and resolution of hardware- and system-level issues using structured methodologies, supporting CAPA and continuous improvement.
• Ensure compliance with regulatory and safety standards, including IEC 60601-1 and IEC 60601-1-2, and support regulatory submissions and audits.
• Drive development of Design History File (DHF) deliverables and contribute to risk management activities (ISO 14971), ensuring full traceability.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• Bachelor’s degree in Electrical Engineering or Biomedical Engineering with 8+ years of experience, or Master’s degree with 6+ years, or PhD with 3+ years experience.
• Experience in medical device development highly desired.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

  Only qualified candidates will be contacted. 

Department:    Algorithm

Reports to:      Algorithm, Senior Manager                

At Enchannel Medical, we’re redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of heart rhythm patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

This Scientist, Staff (Machine Learning & Simulations), will be a key contributor to our algorithm team, working on innovating and developing new research and product features for our cardiac electrophysiology mapping system. They will be responsible for designing, developing, testing, and improving cardiac simulations used for treating cardiac arrhythmia and collaborating closely with a multidisciplinary team to support system integration and product feature advancements. They will have an opportunity to design and build end-to-end solutions.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Develop biophysics-based simulations to predict optimal ablation sites.
• Optimize the simulation compute resources using statistical, machine learning (ML), and optimization techniques to provide real-time feedback.
• Analyze and interpret complex cardiac signals.
• Develop innovative simulation solutions and collaborate with cross-functional teams to integrate simulation outcomes into the software stack.
• Collaborate with the software engineering team to implement algorithms and ML solutions into computationally efficient, “real-time” operations.
• Evaluation, adoption, and refinement of prototype algorithms developed by our engineers, scientists, and consultants.
• Maintain, update, and document design requirements throughout the entire system life cycle. 
• May be required to actively contribute to regulatory filings, patent applications and other industry related publications.
• Responsible for compliance with quality system procedures and all regulatory requirements.
• Consistently promote collaboration, positivity, accountability, and resourcefulness.
• Must demonstrate mutual respect, ongoing communication, and a positive outlook with both internal team members and customers.

Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• 5+ years of related experience and a Bachelor’s and/or Master’s degree, and/or PhD in a scientific/engineering discipline; or equivalent combination of education and experience.
• Must demonstrate expertise in cardiac electrophysiology, with a strong foundation in applying this knowledge to practical applications.
• Hand-ON experience working with cardiac simulation tools.
• Experience with the use of ML in cardiac anatomy and electrophysiology, ECG, unipolar/bipolar electrogram.
• Strong programming skills in languages such as Python, C++, and MATLAB.
• Experience with ML libraries such as OpenCV, TensorFlow, and PyTorch.
• Broad understanding of machine learning, deep learning, and statistical techniques.
• Strong problem-solving abilities, with the capacity to develop innovative solutions for complex technical challenges.
• Excellent collaboration skills to work effectively across multidisciplinary teams, including hardware, software, quality, and regulatory groups.
• Time management and organizational skills to prioritize workload efficiently in a fast-paced startup environment.
• Exceptional verbal and written communication skills, including the ability to explain highly technical concepts to non-technical audiences.
• A results-driven mindset, with the ability to adapt quickly to changing project requirements and deliverables.
• Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field.
• Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed.
• Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes.
• Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others. Must be able to read, write and speak effectively.
• Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork, and remain flexible and open-minded. Able to quickly adapt to change.
• Capable of following realistic plans, goal setting, resource management, contingency planning, coordinating, and cooperating with others.
• Capable of working thoughtfully under pressure and in a timely manner.

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted.