Senior Software Engineer - Urology R & jobs at Boston Scientific in United States, Marlborough

Spencer Gregory Hale

Your responsibilities include:

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
• Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing-related.
• Supports Supplier Change Impact Assessments for process changes at suppliers.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.

New Product Development:

• Execute SFMD Plan deliverables for onboarding of products into BSC’s Quality System.
• Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.
• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:
Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 2 years of relevant experience in quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%.

Preferred Qualifications:

• 3+ years of medical device engineering experience preferred.
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.

Maximum Salary: $ 138300

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.

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.

Your responsibilities will include:

• Test prototypes and components following standard test protocols.
• Organize, coordinate, and execute testing of packaging designs with engineering guidance.
• Support new test methods and/or revise existing test methods.
• Learn and apply standard test methods and processes.
• Prepare reports/documentation to communicate results to the technical community.
• Use developed networks in assisting engineering teams in obtaining necessary materials, services, and test data.
• Assist with problem solving.
• Assist in the set-up of experiments.
• Maintain testing database/tracking system.

Required qualifications:

• 0 – 1yrs with High School Diploma and/or background working in a technical, laboratory, or Quality role or equivalent combination of education/work experience.

Preferred qualifications:

• 0 – 2 years of experience in Packaging or related technical discipline.
• Good written, verbal and interpersonal communication skills.
• Work as a team player
• Good technical aptitude
• Strong attention to detail
• Familiarity with packaging materials
• Basic computer literacy (Excel, Outlook, etc)
• Knowledge related to packaging components (Film, Tyvek, Carton, Labels, Corrugated, Pouches).
• Experience performing visual inspections on Packaging materials preferred.
• Familiarity with ASTM / ISTA package testing requirements preferred.
• Familiarity with the medical device industry, FDA regulations, quality systems, and sterilization preferred.
• Ability to handle multiple tasks and effectively manage priorities.
• Ability to lift boxes up to 30lbs.

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:

Reporting to the Senior Director of MedSurg IT, you will:

• Serve as the primary IT business partner for the Endoscopy division, owning its digital roadmap and aligning technology with business goals.
• Lead enterprise data and AI enablement across both Urology and Endoscopy, scaling data strategies, cloud solutions (AWS, Azure), and governance frameworks and AI initiatives that improve operational efficiency and customer experience.

Digital Strategy & Business Partnership:

• Provide strategic IT leadership for Endoscopy, with ownership of digital roadmap and business alignment
• Act as primary technology business partner between enterprise platform teams and business divisions
• Partner with cross-functional stakeholders to scale digital solutions focused that drive commercial impact and operational excellence
• Translate business requirements into technology strategies and implementation roadmaps
  

Data & AI Strategy & Enablement:

• Lead development and execution of comprehensive data and AI strategies across Urology and Endoscopy divisions
• Partner with enterprise data and AI teams to drive standards and best practices in data governance, quality, and responsible AI adoption
• Champion a data-and AI-driven culture and lead analytics maturity initiatives across business units
• Support implementation of strategic data initiatives that accelerate business programs and decision-making
  

Stakeholder Management & Influence:

• Build and maintain strong relationships with business leaders, serving as trusted technology advisor
• Facilitate alignment between business stakeholders and technology teams on strategic initiatives
• Drive consensus and adoption of digital solutions through effective communication and change management
• Present to and engage senior leadership across all organizational levels on technology strategy and outcomes
  

Program Delivery & Governance:

• Oversee delivery and value measurement of IT programs supporting MedSurg strategic objectives
• Establish scalable processes, frameworks, and governance for digital program execution
• Define and track key performance metrics (KPIs, ROI) to measure value delivery and optimize portfolios
• Ensure programs comply with regulatory, privacy, and security standards
• Monitor and communicate program status, risks, and business value to stakeholders
  

Team & Vendor Management:

• Lead cross-functional project teams, including internal staff and external partners
• Manage vendor relationships, contracts, and service-level agreements for technology solutions
• Mentor and develop talent to build digital capabilities within the organization
• Foster collaborative partnerships across IT and business teams
  

Required qualifications:

• Bachelor’s degree in IT, Computer Science, Engineering, Business, or related field
• 8+ years of IT leadership with people management, cross-functional delivery, and measurable business outcomes
• Proven ability to partner with business leaders and manage stakeholders across all organizational levels
• Experience scaling data-enabled initiatives across multiple business units in complex, matrixed organizations
• Success in developing and operationalizing enterprise data strategies, governance frameworks, and technology roadmaps aligned to business objectives
• Hands-on expertise in data architecture, cloud platforms (AWS or Azure), and modern digital ecosystems
• Exceptional communication and presentation skills for engaging diverse stakeholders and senior leadership
  

Preferred qualifications:

• Proven ability to collaborate with sales and other customer-facing teams to align IT solutions with business objectives
• Healthcare, medical technology, or regulated industry experience
• Background in change management and organizational transformation initiatives

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:

You will leverage deep technical expertise in C++ application development, the Linux operating system, and cybersecurity to architect, develop, and deliver robust, secure, and scalable systems. Your work will span the full software development lifecycle — from concept through commercialization — within a highly regulated environment.

Your responsibilities will include:

• Design, develop and release innovative high performance medical device software.
• Prototype and implement solutions in C++ ensuring high efficiency and maintainability.
• Provide technical knowledge to the team in software design and best in class software development methodologies and practices.
• Partner with other teams including marketing, systems engineering, QA, hardware and regulatory to understand requirements and bring the best solutions forward.
• Understands customer requirements and how they translate to application features.
• Implements, tests, troubleshoots, and debugs source code for software applications.
• Support testing strategies (Unit/Integration) and design verification protocols to verify software.
• Conducting code reviews and providing feedback to ensure adherence to best practices and coding standards.
• Follow the full design life cycle process including driving efforts in requirements specification, design activities, planning, code reviews and creating corresponding artifacts.
• Participating 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.
• Dedication to and enthusiasm for building products that save and improve lives.

Required qualifications:

• Bachelor’s degree or higher in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, or related major
• 5+ years of software development with fluency coding in multiple programming languages
• 1+ years of software development experience in medical device, aerospace, automotive, or defense products (medical device preferred).
• Strong oral and written communication skills
• Strong in solving complex problems and demonstrated ability to adapt, proactive and a positive influence on the rest of the team.
• Broad and deep technology experience including networking and cybersecurity.
• Expertise in Linux operating system deployment, customization, and security hardening.
• Proficiency in C++ (C++11 or newer), with experience developing coding standards and secure coding practices.

Preferred qualifications:

• Experience with software configuration management tools for source code control (Git), issue tracking (Jira), requirements management (Cockpit), code review tools (Code Collaborator) and 3rd party project build tools
• Experience in the medical device industry
• Experience with medical device regulatory standards including IEC 62304, 60601, FDA 510(k), ISO 14971, 13485
• Knowledge of cybersecurity best practices and standards

Base Salary Range

Minimum Salary: $ 86600

Maximum Salary: $ 164500

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

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.

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

Spencer Gregory Hale

Sustaining Engineering:

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Manages sustaining quality issues, process change impacts, and design change implementations in the BSC Quality System.
• Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.
• Investigates complaints and manages NCEPs at OEM suppliers where the issue is manufacturing related.
• Lead investigations into supplier-related nonconformances and implement effective Corrective and preventive actions (CAPA)
• Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.

New Product Development:

• Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
• Review and approve Supplier documentation including validation protocols (IQ/OQ/PQ) , FMEAs, control plans and inspection methods.

Quality System Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
• Identifies and advises management on potential improvements to quality systems and processes in the company.

• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:

Minimal Qualifications:

• BS degree in engineering or technical field with minimum of 5 years of relevant experience in supplier engineering, supplier management, or supplier quality engineering.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Experience with capital equipment or electronics including product development, servicing, and repair.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, SCAR.
• Ability to work independently; organized and self-driven.
• Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Domestic and international travel up to 25%. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.

Preferred Qualifications:

• 7+ years of medical device engineering experience preferred.
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

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.

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 this role:

As a Senior Clinical Evaluation Scientist, you will develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.

Your responsibilities will include:

• Apply analytical and methodical clinical evaluation approaches to develop benefit-risk profiles for Boston Scientific’s interventional cardiology devices.
• Author and maintain clinical documentation including CERs, PMCF reports, and SSCPs in alignment with regulatory standards.
• Collaborate cross-functionally to ensure clinical content supports product approvals, indication expansions, claims, and post-market requirements.
• Interpret and synthesize data from multiple sources to produce high-quality, compliant clinical evaluations.
• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
• Collaborate with leadership and cross-functional partners to ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
• Aid in the development and execution of strategies for regulatory responses for regulatory submissions

Required qualifications:

• Minimum bachelor’s degree and 4 years of medical writing experience
• Analytical skills, including strong familiarity with medical literature
• Proven experience writing clinical evaluation reports
• Proven experience applying principles of EU MDR

Preferred qualifications:

• Preferred medical device industry experience or knowledge of interventional cardiology and related disease states
• Proven and demonstrated ability to understand engineering documentation, including risk documentation
• Proven experience with regulatory body communications

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.