דרושים R&d Systems Verification Lead - Electrophysiology ב-Boston Scientific ב-United States, Waltham

We are looking for an experienced Senior Systems Engineer to become a member of a dynamic team that provides technical leadership with a mix of mechanical, electrical, software, and catheter engineers and an interdisciplinary team of Marketing, Regulatory, and Quality. This individual will work on new projects from concept to commercialization and projects that maintain our currently released mapping system. The individual will be responsible for defining, analyzing and implementing system requirements, risk analysis, and usability as well as provide input to cross-functional deliverables.

Key Responsibilities:

• Provides technical leadership on a cross-functional engineering team.
• Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
• Solve system problems by analyzing the situation and recommending corrective or alternative actions.
• Documents system architecture and design control elements by writing documents, reports, and memos.
• Translates customer needs into technical requirements, engaging the field, marketing, service and other functions as needed.
• Provides expertise and conducts evaluation of validation and verification activities.
• Directs and assist with industry-based standards testing for safety and EMC according to 60601-1
• Drives the risk analysis for the project.
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.

Qualifications:

• Engineering degree (EE, computer science, or biomedical) and experience driving projects and tasks to closure.
• 5+ Years of experience within the Medical Device industry with BS degree, 3+ Years with MS or PhD
• Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).
• Experience conducting simulations, mathematical analysis and/or system interaction analysis.
• At least 5 years of engineering experience in mixed HW/SW systems.
• Technical experience with digital and analog low noise systems.
• Usability engineering experience.
• Strong communications and time management abilities.
• Ability to provide technical leadership within cross-functional teams.
• Track record of independent and solution-oriented work style.

This is a hybrid position based in Waltham, MA.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

The Senior Concept Development Engineer will have a collaborative role in the design and development of novel algorithms and tools for cutting-edge medical applications in the field of Cardiac Electrophysiology. The primary responsibilities include: ideating novel concepts, rapidly prototyping solutions, creating and analyzing technical data and communicating high level data-driven decisions.

Your responsibilities include:

• Develop engineering solutions and investigate competitive technologies related to Cardiac Electrophysiology

• Play an active role in the cross-functional/departmental effort of defining the clinical feature value proposition.

• Support the establishment and execution of detailed project plans and milestones to drive towards feasibility assessment.

• Explore, model, and develop new algorithms and ideas for breakthrough mapping and automated sensing features and the methods by which we assess their performance

• Effectively collaborate across disciplines (HW, Software, Systems, and ME) to focus on and maximize end-to-end solution value

• Stay current with industry trends and new methodologies including artificial intelligence and machine learning

Qualifications:

• Master’s Degree in Biomedical Engineering/Computer Science/Electrical Engineering or equivalent with at least 2 years of product development experience in a commercial environment.

• Demonstrated expertise in MATLAB/Python or equivalent for prototyping, modeling and analysis

• Domain Expertise in Cardiac Electrophysiology or applicable field

• Creative Solution oriented mindset

• Strong knowledge of data structures, Mathematics and Applied statistics

• Ability to work with ambiguity to balance risk and opportunity.

Preferred Qualifications:

• PhD in Biomedical Engineering/Computer Science with Signal/Image processing or Algorithm/Method Development background

• Experience with Impedance Tomography and/or navigation algorithms

• Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner

• Familiarity with lab equipment (signal generator, oscilloscope, LabView, etc.)

• Prior experience with optimization, inverse problems and machine learning techniques

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

We are looking for an experienced Senior Systems Engineer to become a member of a dynamic team that provides technical leadership with a mix of mechanical, electrical, software, and catheter engineers and an interdisciplinary team of Marketing, Regulatory, and Quality. This individual will work on new projects from concept to commercialization and projects that maintain our currently released mapping system. The individual will be responsible for defining, analyzing and implementing system requirements, risk analysis, and usability as well as provide input to cross-functional deliverables.

Key Responsibilities:

• Provides technical leadership on a cross-functional engineering team.
• Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
• Solve system problems by analyzing the situation and recommending corrective or alternative actions.
• Documents system architecture and design control elements by writing documents, reports, and memos.
• Translates customer needs into technical requirements, engaging the field, marketing, service and other functions as needed.
• Provides expertise and conducts evaluation of validation and verification activities.
• Directs and assist with industry-based standards testing for safety and EMC according to 60601-1
• Drives the risk analysis for the project.
• Works with a cross-functional team and serves as an R&D representative on cross-functional deliverables.

Qualifications:

• Engineering degree (EE, computer science, or biomedical) and experience driving projects and tasks to closure.
• 5+ Years of experience within the Medical Device industry with BS degree, 3+ Years with MS or PhD
• Medical Device experience working with imaging and signal processing systems (EEG, Electrophysiology, etc.).
• Experience conducting simulations, mathematical analysis and/or system interaction analysis.
• At least 5 years of engineering experience in mixed HW/SW systems.
• Technical experience with digital and analog low noise systems.
• Usability engineering experience.
• Strong communications and time management abilities.
• Ability to provide technical leadership within cross-functional teams.
• Track record of independent and solution-oriented work style.

This is a hybrid position based in Waltham, MA.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

The Senior Concept Development Engineer will have a collaborative role in the design and development of novel algorithms and tools for cutting-edge medical applications in the field of Cardiac Electrophysiology. The primary responsibilities include ideating novel concepts, rapidly prototyping solutions, creating and analyzing technical data and communicating high level data-driven decisions.

Your responsibilities include:

• Design and develop novel processing algorithms applied to biological signals.

• Contribute to feasibility validation in preparation for transfer to commercial integration.

• Collaborate within Concept Development Team to ideate, prototype, and refine new algorithmic approaches.

• Write clean, maintainable, well-documented code and contribute to technical documentation.

• Effectively collaborate across disciplines (HW, Software, Systems, and ME) to focus on and maximize end-to-end solution value.

• Play an active role in the cross-functional/departmental effort of defining the clinical feature value proposition.

• Apply best practices in algorithm development and contribute to continuous improvement of development workflows.

• Stay current on emerging methodologies, including artificial intelligence and machine learning, and apply relevant techniques to ongoing projects.

Requirements:

• Master’s degree in Computer Science, Electrical Engineering, Biomedical Engineering, or a related field.

• 5+ years of experience in product development within a commercial or regulated environment.

• Proficiency in C++ and MATLAB/Python or equivalent for prototyping, modeling, data analysis and application development.

• Experience in multithreaded application development that includes testing and debugging C/C++ on Linux.

• Familiarity with modern source code management tools (e.g., Git; experience with AccuRev is a plus).

• Strong knowledge of data structures, Mathematics and Applied statistics.

• Experience in Continuous Integration/Continuous Deployment (CI/CD) software practice in a regulated environment.

• Domain expertise in medical applications or biomedical signal processing.

• Creative, solution-oriented mindset with a passion for innovation.

• Ability to work with ambiguity to balance risk and opportunity.

• Excellent communication and presentation skills, with the ability to convey technical information clearly and thoroughly.

• Prior experience with optimization, inverse problems and machine learning.

• Comfortable debugging complex integrated systems spanning hardware, embedded and application software in medical devices.

• Demonstrated history of learning new platforms and development environments to best meet project needs.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

As part of the software development team, you will lead the creation of high-performance rendering and workflow tools. You will collaborate closely with hardware engineers, systems engineers, clinical teams, and field technicians to create cutting-edge tools for physicians and care teams. The role will involve full lifecycle software development, including requirements, architecture, design, implementation, and validation.

Your responsibilities will include:

• Generate UI concepts and implement prototypes to gather user feedback on workflow and usability

• Design and build elegant solutions for complex clinical problems in user interaction and visualization

• Lead enhancements for real-time 3D rendering and advanced visualization technology

• Collaborate effectively with hardware, systems, quality, and test teams to ensure end-to-end solution integrity

• Participate in preclinical system experiments with physicians and third parties to evaluate system performance

• Implement, test, troubleshoot, and debug source code for complex medical software applications

• Drive software development through the full product lifecycle, including requirements, design, planning, code reviews, and documentation

• Contribute to technical documentation such as design specifications, test plans, and user manuals

• Foster a culture of pragmatic decision-making and cross-functional collaboration

• Identify and drive continuous improvements in development tools and processes

• Support field clinical staff with software use and issue troubleshooting

Required Qualifications:

• BS or MS in Computer Science or a related field

• Minimum of 5 years' experience in software development

• Strong programming experience in C++

• Experience with OpenGL and 3D graphics programming

• Solid understanding of object-oriented programming principles

• Excellent analytical and problem-solving skills

• Demonstrated ability to understand user needs and design intuitive user interfaces

• Ability to manage multiple projects in parallel

• Experience with full software development lifecycle processes

• Strong communication skills, both written and verbal

Preferred Qualifications:

• Experience with Qt (QML is a plus)

• Experience developing on Linux platforms

• Familiarity with Agile and Scrum methodologies

• Understanding of medical device standards such as IEC 62304, IEC 60601, ISO 14971, ISO 13485

• Experience with software tools such as Git, Jira, and JAMA

• Experience mentoring junior engineers

• Quick learner with adaptability to master complex systems and new technologies

Working conditions:

• Hybrid work model

• Travel: 0–10%

Maximum Salary: $ 197000

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

As an Intern performing your cardiac rotation at Boston Scientific, you will…

• Gain real life experience learning how to process, analyze, and interpret rhythms with real patients and live Events
• Have an entire Education Team building and developing your skills, providing feedback and coaching along the way
• Complete a 30-day training program to be an independent monitoring Tech
• Have an opportunity to join a large corporation, understand the business model for an IDTF, and begin a career in ECG
• Learn time management, networking, and multiple operating systems

Examples of meaningful work by an Intern:

• Process, analyze, interpret and edit EKG data
• Collect recordings and patient symptoms as needed
• Facilitate activation of EMS, if indicated
• Accurately document actions taken within patient records
• Obtain patient transmissions and related symptoms
• Recognize abnormal cardiac rhythms/symptoms, and clearly communicate information to appropriate team member
• Retain information that is job specific such as safety regulations and current policies and procedures

Your Qualifications:

• Enrolled in or completing an ECG, Telemetry, or rhythm analysis course.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the Role:

The Opal HDx Mapping System centers around a real-time virtual world of the human heart. As a physician probes the heart with a catheter, the system generates an accurate anatomical model of the chamber. High-performance rendering and algorithmic techniques are vital to creating a stunning view and providing the physician with instant feedback.

Our technology includes C++ (C++11 or newer), Linux, MATLAB

Key Responsibilities:

The Senior Software Engineer will have a key role in the development of algorithms for cutting edge medical applications in the field of Cardiac arrhythmia diagnosis and treatment. The responsibilities will include:

• Provide technical leadership to the team in software architecture and best in class software development methodologies and practices.
• Architect, design, develop and release innovative high performance medical device software.
• Solve difficult problems, improve state of the art, and achieve engineering excellence.

• Collaborate across disciplines effectively (HW, Systems, Test, Quality, Regulatory) to focus and maximize end-to-end solution value and quality

• Participates in preclinical system experiments in the lab, with physicians, and 3rd parties

Requirements:

• BS/MS in Computer Science or equivalent experience, with a strong software development background.

• 5+ years relevant Experience
• C++ development and debugging Experience

• Algorithm development experience using MATLAB

• Experience with Object Oriented programming principles

• Excellent analytical and problem-solving skills
• Ability to contribute to multiple projects in parallel
• Implements, tests, troubleshoots, and debugs source code for complex software applications
• Follow the full design life cycle process including driving efforts in requirements specification, design activities, planning, code reviews and creating corresponding artifacts.
• Participate in the development of technical documentation, including design specifications, test plans, and user manuals.
• Promote a collaborative environment and pragmatic engineering decision-making.
• Identify and implement continuous improvements to work processes and tools.
• Support field clinical staff on use of medical software and troubleshooting of issues.

Preferred Qualifications:

• Experience with developing on the Linux platform

• Experience with scrum framework

• Good written and verbal communication skills. General report writing/documentation experience
• Experience with medical device standards including IEC 62304, 60601, ISO 14971, 13485

• Experience with software configuration management tools for source code control (Git), issue tracking (Jira), requirements management (JAMA)
• A good learner who can master complex software and quickly adapt to new tools and technologies.
• Experience mentoring lower-level engineers

• Hybrid Work Mode
• Travel 0-10%

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.