Senior Systems Test Supervisor jobs at Boston Scientific

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.

Maximum Salary: $ 71552

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.

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.

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 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
• 5+ years of relevant professional background with a Bachelor’s degree, or 3+ years with a Master’s degree, demonstrating consistent delivery of high-quality software solutions
• At least 3 years of hands-on test automation expertise, including the design, development, and execution of automated test suites improving efficiency
• Expert-level proficiency in Python, with the ability to architect scalable frameworks, optimize code for performance, and mentor others in best practices
• Proven technical leadership, evidenced by leading cross-functional teams, driving complex projects to completion, mentorship, and influencing technical direction to achieve measurable 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: $ 156900

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.

Spencer Gregory Hale

About the role:

The Sr Quality System Engineer will serve as a Quality representative to improve awareness, visibility and communication on quality initiatives and objectives, and will support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Specifically, this role will support the Corrective and Preventive Action (CAPA) program at Maple Grove and ensure compliance to CAPA processes, Medical Device regulations and BSC Quality System requirements.

This is a hybrid work mode position located in Maple Grove, MN with the expectation to be in the office 3 days per week.

Your responsibilities include:

• Mentoring cross-functional CAPA teams on:
  • applying quality tools and techniques to identify root causes and create sustainable solutions to product and/or system issues
  • using project management best practices to effectively coordinate activities, communicate progress, collaborate on key deliverables and meet critical CAPA phase timelines
  • creating robust, compliant and timely records, using the electronic CAPA database system
• Providing continuous and rigorous assessment of CAPA activities and review of documentation throughout the CAPA lifecycle to ensure compliance with global BSC CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements
• Providing guidance to the CAPA team on activities, such as root cause analysis, corrective action plans and effectiveness verifications, and advising the team on applying sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve systemic quality issues
• Being a subject matter expert in matters relating to CAPA at the Maple Grove site with the ability to make sound decisions and provide guidance regarding how to best apply the processes efficiently, effectively, and compliantly
• Determining and tracking actionable CAPA metrics and trends to ensure proper execution and effectiveness of the site CAPA program, including influencing key stake holders as appropriate
• Supporting both site and global scale CAPA initiatives, continuous improvement opportunities and/or projects

Required Qualifications:

• Bachelor's degree and 5+ years or Master's degree and 3+ years of experience in a medical device manufacturing, quality or regulatory/compliance environment
• Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
• Technical writing and documentation skills
• Attention to detail and ability to analyze information quickly
• Use a risk-based approach for making quality and business decisions

Preferred Qualifications:

• Degree(s) in Science or Engineering
• 5+ years of experience in Quality Systems and/or CAPA management
• Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
• Proficiency in Power BI and Tableau data reporting tools
• Proactive, able to work independently, as a team leader or member, and enjoy being part of a highly visible team
• Ability to collaborate and communicate with all levels of the organization
• Continuous improvement mindset with a passion for Quality
• Hands-on Project Management experience

Maximum Salary: $ 156900

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.

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.

Your responsibilities will include:

• Determines clear and specific priorities for the development of new products and product enhancements by defining customer needs and working with other internal functional groups.
• Drive “Voice of Customer” (VOC) throughout the technology development process to ensure market specifications are incorporated throughout each project phase. Execute and participate in multiple physician advisory boards ensuring all HCP engagements are managed in accordance with compliance policies.

• Oversee the product portfolio pipeline, making strategic recommendations to optimize product offerings and drive future growth. Understand customer unmet needs and translate them into future pipeline recommendations.
• Act as Marketing Lead on project core teams. Be an integral part of new product development teams, contributing to the ideation, development, and launch of innovative products.
• Create business cases and investment proposals for new products, preparing ROI analyses, and schedules for new product launches.

• Consolidates and disseminates a deep understanding of the competitive global PI landscape. Contribute to understanding key industry dynamics in formulating technology, clinical and commercial strategies.

Required qualifications:

• Bachelor's degree in business, engineering, or related field preferred
• 5+ years of upstream marketing, product management, or strategic marketing experience in the medical device industry
• Strong analytical, quantitative, and strategic thinking skills
• Ability to travel up to 30% in support of tradeshows, internal meetings and customer programs; some international travel may be required

Preferred qualifications:

• Advanced degree (such as MBA)
• Experience with market and revenue modeling
• Experience with KOL engagement and managing physician collaborators
• Demonstrated ability to develop deep clinical or technical expertise
• Ability to collaborate with commercial and finance teams to define and implement effective business models

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.