Principal Statistician jobs at Boston Scientific

About the role:

Our technologies encompass 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths to diagnose and treat heart rhythm disorders.

Your responsibilities will include:

• • Maintaining advanced clinical knowledge of EP diagnostic and ablation technologies, PFA, mapping and recording systems, transeptal access tools, and left atrial appendage occlusion technologies I add

• • Attending procedures in cardiac CV/EP labs to provide clinical support on Boston Scientific AF Solutions products, including the , , transeptal access tools, diagnostic and therapeutic catheters, and devices

• • Educating customers on clinical usage and benefits of AF Solutions products through customized presentations, demonstrations, and ongoing training

• • Meeting with physicians and clinical stakeholders to assess their needs and demonstrate how Boston Scientific products support optimal patient outcomes

• • Developing relationships with hospital staff, physicians, and administrators to expand influence across departments and facilitate strategic decision-making

• • Responding to clinical and technical inquiries by collaborating across functions including sales, clinical research, marketing, and technical support

• • Demonstrating change leadership and collaborating cross-functionally to align local activities with broader strategic goals

• • Implementing strategies outlined in quarterly action plans and coordinating efforts with sales teams to advance business objectives

• • Supporting physician education and market development by engaging referring physicians, fellows, and key opinion leaders

• • Training on and adhering to clinical trial protocols and compliance standards in line with global regulatory expectations

• • Managing clinical trial activity within the territory , including Interest Visits and Site Initiation Visits, and educating investigators on study procedures and products

Required qualifications:

• • Minimum of a bachelor’s degree (or equivalent experience).

• • Minimum of 6 years of 3D cardiac mapping system experience or minimum of 10 years in medical device sales, clinical electrophysiology or equivalent education and experience.

• • Must demonstrate technical aptitude, and ability to discuss & explain complex technical product information.

Preferred qualifications:

• • NASPE/IBHRE CEPS certification.
  • Work experience in Atrial Fibrillation/Cardiac Mapping/Structural Heart Procedure.
  • Existing usage of 3D cardiac mapping system.
  • MS or advanced degree in business or healthcare.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug 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 includesC++, Linux, I2C, MQTT, Ethernet, TCP/IP.

Key Responsibilities:

The Principal Software Engineer will have a key role in the development of communication protocols 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.
• 8+ years relevant experience
• Proficiency with Modern C++ (11’ or newer)
• Linux Experience

• I2C Experience
• MQTT Experience

• Ethernet and TCP/IP TEI Experience

• Experience with Embedded Systems and 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: $ 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.

The Opal 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 electro-anatomical model of the chamber. High-performance rendering and algorithmic/signal processing techniques are vital for creating a stunning view of the hearth’s chamber and providing instant feedback to the physician. The mapping system also provides a suite of data-analytical and graphing tools under an intuitive GUI, aiding the physician to administer the right therapy to the patient.

responsible for ensuring the safe, efficient, predictable, and repeatable creation of our medical applications. The Senior Linux Release Engineer will ensure timely release of our software medical applications all the way from development to execution and deployment.

Our development tools include Linux, C++, QT, OpenGL, GLSL, OpenCL

Key Responsibilities:

• Create hardened Linux operating system releases for our medical device
• Develop, enhance and maintain Linux kernel packages, device drivers, and system libraries
• Work on custom device drivers to complete end-to-end solution
• Work on performance tuning, debugging, and troubleshooting of Linux system
• Analyze and resolve Linux security vulnerabilities
• Proactively engage with other cross functional teams to resolve problems and design solutions
• Proactively identify and remove roadblocks on behalf of the team. This may include debugging build issues and fixing problems in a timely manner
• Clearly and regularly communicate with development team, QA, technical directors, and product owners
• Provides technical guidance and support to other team members as needed
• Perform code reviews, unit testing, and integration testing for kernel and low-level software modules
• Embrace new technologies and best practices

Requirements:

• A bachelor’s degree in computer programming, computer science, information technology, or equivalent experience
• Strong expertise with C++/C programming
• In-depth understanding of Linux internals
• Familiarity with system profiling and performance tuning tools like perf, gdb, valgrind, and eBPF
• Knowledge of file systems, networking stack, and security mechanism in Linux
• Excellent written and verbal communication skills
• Ability to work independently and complete projects with minimal supervision
• Advanced knowledge of software development lifecycle
• Can collaborate well with teams and stakeholders as needed

Preferred Qualifications:

• Extensive experience with designing and implementing medical device software
• Knowledge of hardware interfaces, buses (PCIe, I2C, SPI), and firmware interactions.
• Exposure to secure coding practices and kernel hardening techniques

Working Conditions
• Hybrid Work Mode
• 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.

About the role:

The successful candidate will participate in medical device software verification and validation in collaboration with cross functional teams. Testing medical device application requires rigor and attention to detail to meet industry and regulatory standards. We’re looking for a motivated and creative SW application test engineer with a focus on quality who has experience with requirements-based software test automation.

Your role will include:

• Oversee planning, designing, and executing test strategies to ensure alignment with project goals and regulatory standards.
• Coordinate and prioritize test activities within projects, while facilitating communication among cross-functional teams regarding objectives, timelines, and deliverables.
• Provide mentorship and technical guidance to less experienced test engineers, supporting their growth and knowledge sharing.
• Develop, track, and present test metrics, progress, and quality reports to senior management.
• Lead root cause analysis of test failures, coordinate resolutions, and support continuous improvement by evaluating new tools and best practices.
• Ensure traceability of test cases to requirements, compliance with industry standards, and represent the test team in meetings, audits, and reviews.

Minimum qualifications:

• Bachelor’s degree or higher in Computer Science or related technical discipline
• 8+ years of relevant professional background with a Bachelor’s degree, or 5+ years with a Master’s degree, demonstrating consistent delivery of high-quality software solutions
• 5+ years of hands-on test automation expertise, including the design, development, and execution of automated test suites that improved efficiency and reduced manual testing effort
• Expert-level proficiency in Python, with the ability to architect scalable frameworks, optimize code for performance, and mentor others in best practices
• Demonstrated technical leadership including leading cross-functional teams, guiding complex projects from conception to successful delivery, and shaping technical strategy to achieve measurable business and product outcomes

Preferred qualifications:

• Background working with BDD (Behavior Driven Development) practices and proficiency in and Gherkin syntax
• Skilled in designing test infrastructure and selecting appropriate tools for implementation
• Familiarity with Windows services and desktop application development
• Proficiency with tools such as Jira, Jama Connect, Bitbucket, Git, and Jenkins
• Proven track record contributing to medical device projects in Agile environments, with adherence to IEC 62304 and IEC 60601 standards
• Knowledge of Secure Software Development Life Cycle (SSDLC) methodologies
• Competence in scripting and automation using PowerShell and Python
• Hands-on testing capabilities in C#, C++, HTTP, and MQTT
• Ability to install, configure, and troubleshoot Windows-based environments
• Strong understanding of network analysis tools such as tcpdump, nmap, and Wireshark
• Excellent verbal and written communication skills, with the ability to convey technical concepts clearly

Maximum Salary: $ 188300

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:

Our technologies encompass 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths to diagnose and treat heart rhythm disorders.

In this field-based role, the Electrophysiology Mapping Specialist will begin with an intensive training and development program to gain in-depth knowledge of our technologies and prepare for success. Upon completion, the specialist will provide expert clinical, technical, and educational support to physicians, EP Lab staff, and sales representatives during cardiac procedures using the

Your responsibilities will include:

• Maintaining advanced clinical knowledgeof EP diagnostic and ablation technologies, PFA, mapping and recording systems, transeptal access tools, and left atrial appendage occlusion technologies I add
• Attending procedures in cardiac CV/EP labsto provide clinical support on Boston Scientific AF Solutions products, including the,, transeptal access tools, diagnostic and therapeutic catheters, and

• on clinical usage and benefits of AF Solutions products through customized presentations, demonstrations, and ongoing training

• Meeting with physicians and clinical stakeholders

• Developing relationshipswith hospital staff, physicians, and administrators to expand influence across departments and facilitate strategic decision-making

• Responding to clinical and technical inquiries

• Demonstrating change leadership

• Implementing strategies outlined in quarterly action plans

• Supporting physician education and market developmentby engaging referring physicians, fellows, and key opinion leaders

• Training on and adhering to clinical trial protocols and compliance standardsin line with global regulatory expectations

• Managing clinical trial activity within the territory, including Interest Visits and Site Initiation Visits, and educating investigators on study procedures and products

Required Qualifications:

• Bachelor’s degree (or equivalent experience).

• Minimum of 6 years of 3D cardiac mapping system experience or minimum of 10 years in medical device sales, clinical electrophysiology or equivalent education and experience.

• Must demonstrate technical aptitude, and ability to discuss & explain complex technical product information.

Preferred Qualifications:

• NASPE/IBHRE CEPS certification.
• Work experience in Atrial Fibrillation/Cardiac Mapping/Structural Heart Procedure.
• Existing usage of 3D cardiac mapping system.
• MS or advanced degree in business or healthcare.

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

About the role:

You will also contribute to our AI vision by mentoring colleagues, shaping technical direction, and ensuring ethical, trustworthy AI practices are embedded in everything we do. This is an exciting opportunity to influence enterprise innovation and bring cutting-edge technology into real-world impact across a global organization.

Your responsibilities will include:

• Design, develop, and deploy predictive and prescriptive AI/ML models to support cross-functional business initiatives
• Collaborate with business leaders to identify valuable data assets and define impactful, enterprise-aligned use cases
• Partner with enterprise leadership to define and evolve Boston Scientific’s AI/ML and data science strategy
• Work closely with Data Architects, Data Engineers, and Product Managers to develop data pipelines, model integration, and deployment workflows
• Ensure adherence to data privacy regulations (e.g., GDPR, HIPAA) and promote ethical and responsible use of AI technologies
• Mentor and coach junior data scientists and engineers, fostering a collaborative learning environment
• Stay informed of advancements in AI/ML/GenAI and advocate for adoption through enterprise communities of practice

Required qualifications:

• Bachelors degree in Data Science, Statistics, Mathematics, Computer Science, Engineering, or a related field
• Minimum of 5 years' experience in applied data science, machine learning, or AI solution development
• Proven ability to mentor technical professionals and/or lead small teams
• Strong technical expertise in statistical modeling, machine learning techniques, and business problem solving
• Excellent communication skills with the ability to explain complex technical concepts to non-technical audiences
• Demonstrated success in initiating and delivering enterprise data science projects in collaboration with business stakeholders

Preferred qualifications:

• Master's degree or higher in Data Science, Statistics, Mathematics, Computer Science, Engineering, or a related field
• Experience applying AI/ML techniques within finance, sales, marketing, or other regulated environments
• Proficiency in Python, SQL, cloud platforms (AWS, Azure, Snowflake), and ML Ops tools
• Familiarity with Agile and DevOps methodologies for data science projects

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.

About the role:

This is a hybrid position (in office minimum three days per week) based in Maple Grove, Minnesota (preferred) or Marlborough, MA.

Your responsibilities will include:

• Lead and represent RA on cross functional projects in new product development and may include manufacturing process changes
• Develop domestic and international strategies for regulatory approval of Class II and III medical devices. This includes strategies for IDE approvals in the US.
• Coordinate, compile, and submit US regulatory filings for new and modified products, including IDEs, IDE Supplements, PMAs, PMA Supplements, pre-submissions, 510(k)s, PMA & IDE Annual Reports
• Support EU submissions for new clinical trials
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
• Develop and maintain positive relationships with regulatory agency staff
  Lead and/or participate in regulatory audits, as required

Required qualifications:

• Minimum of a Bachelor's Degree
• 7+ years of experience in Regulatory Affairs or 5+ years of experience in Regulatory Affairs with other relevant experience
• Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects
• Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing and business strategies for global product commercialization
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as IDEs, pre-submissions, original PMAs, PMA Supplements, 510(k)s, and MDR Technical Documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• Bachelor's Degree in life sciences, engineering, healthcare or related field
• Previous experience in the medical device industry with Class II and III device submissions
• Experience working directly with FDA, notified bodies and/or international health authorities
• Demonstrated leadership, strategic thinking, project planning, and project management skills
• Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies
• Able to work independently with minimal supervision
• Strong technical, research and problem-solving skills
• Demonstrated ability to mentor junior regulatory staff members to aid in their development
• Able to work well in fast-paced cross-functional team environments
• Ability to articulate complex ideas clearly both verbally and in writing
• Demonstrated ability to develop strong relationships with regulatory agency staff
• Demonstrated ability to effectively lead multiple regulatory projects and priorities

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.