Principal Scientist - Global Sterility Assurance jobs at Boston Scientific

Responsibilities:

Assist in process optimization projects for the regulatory affairs area (e.g. database maintenance, regulatory controls, automation).
Perform data analysis and report findings.
Process mapping to identify areas for optimization and automation

Requirements

Desirable skills or interests:

skills to clean and preprocess data to ensure its accuracy and consistency;
Interests in programming languages, scripts for task automation, database management

About the role:

The Quality Technician I role in Core Tech Polymers (CTP) is the first point of contact for production personnel regarding quality issues.  The quality technician is responsible for documenting non-conforming events as well as identifying and segregating impacted material.  The position requires creative thinking and investigation skills to resolve problems that arise on extrusion production floor. The quality technician will be responsible for supporting multiple production lines to keep material flowing and assuring quality requirements are maintained throughout the process. Technical aptitude will be a key component as much of the technician role involves working with technology systems including MES, SAP, downtime tracking, and DataMetrics among others.

Your responsibilities will include:

• Investigate and document non-conforming events in eCAPA system
• Perform project and product testing
• Assist engineers in failure analysis
• Provide direct quality support for day to day production floor operations
• Learn and create setups in Statistical Process Monitoring (SPC) program
• Lead and participate in continuous improvement projects
• Assist with quality issues and quality metrics related activities.
• Document non-conforming events and quarantine impacted material
• Perform testing, gather data, and analyze results of product testing and process monitoring.
• Assist with CAPA activities
• Use documentation systems to research information and generate Change Requests.
• Assist in the investigation and disposition of nonconforming materials, designs and/or systems.
• Review device history records (DHR) and acceptance records to ensure all activities in the Device Master Record (DMR) have been performed and approved.
• Update databases and spreadsheets used to track, monitor, and report department activities.
• Use the inventory and traceability management systems to transact and research material
• Communicate with a wide variety of BSC personnel in and outside of the plant.

Required qualifications:

• High school diploma/degree/equivalent work experience

Preferred qualifications:

• 1-2+ years’ experience in a manufacturing environment
• Proficient in Microsoft office (Excel, Word, PowerPoint, etc)
• Strong verbal/written communication skills
• AA degree or higher
• 1-2 years in the medical device field
• Experience in SAP/MES or equivalent MRP system
• Lean manufacturing experience
• Workstation error proofing experience

Maximum Salary: $ 63856

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.

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Key Responsibilities

• Uses problem-solving methodologies to support issue investigations and make improvements.
• Actively interacts with cross-functional team members through face-to-face meetings, virtual video calls, emails or group sessions.
• Practices good teamwork by actively listening, sharing ideas and working together as one team, in support of day-to-day operating requirements.
• Assists in the development and analysis of process, product, material or equipment specifications and performance requirements
• Evaluates new equipment/processes/chemicals for environmental impact to eliminate or lessen such impacts in conjunction with Environmental Health and Safety (EHS)As part of personal development, may assume engineering responsibility for manufacturing equipment or processes within the cleanroom environment.
• Interfaces with vendors, possibly physicians and other technical consultants as part of the role.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements in Standard Operating Procedures.

Education & Experience

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)
• An understanding of systems and a willingness to learn and develop technical skills.
• Good communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.
• Eager to learn and active participate.
• Strong interpersonal skills.

• Eligible to work in Ireland.

• Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.

• – opportunity to transform the lives of patients worldwide.
• Our Culture- our work is guided by core values that define our culture and empower our employees.
• Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.
• Opportunity to Innovate– we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.
• Work-Life Balance– we have created a culture that acknowledges, respects and supports your life and work choices.
• Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

To search and apply for open positions, visit:

Your responsibilites will include:

• Lead development of therapy awareness and referrer engagement strategies for renal denervation.
• Develop and implement global launch plans, emphasizing education and awareness initiatives aimed at healthcare providers and key opinion leaders.
• Conduct comprehensive market research, including physician/healthcare providers advisory boards, qualitative and quantitative surveys, with a focus on therapy adoption and awareness.
• Monitor and analyze the global competitive landscape, identifying opportunities to enhance therapy visibility.
• Cultivate relationships with healthcare providers, decision-makers, and key opinion leaders.
• Support activities for renal denervation therapy development, ensuring therapy benefits and features are effectively communicated.
• Collaborate with cross-functional teams to foster therapy awareness through educational campaigns, professional engagements, and publications.

Required qualifications:

• Bachelor’s degree in Business, Marketing, Life Sciences, Engineering, or related field.
• Minimum of 5 years’ experience in medical device or healthcare marketing/strategy.
• Proven success in engaging Key Opinion Leaders and promoting therapy adoption.
• Ability to travel up to 30% domestically and internationally.

Preferred qualifications:

• MBA or advanced degree in a relevant discipline.
• Strong ability to influence and engage cross-functional teams.
• Excellent communication, presentation, and relationship-building skills.
• Demonstrated success in working collaboratively within a team-based environment and with external stakeholders to increase therapy awareness

Maximum Salary: $ 232000

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 ideal Principal Design Quality Assurance Engineer will bring their leadership to new product development projects and sustaining projects for our innovative electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Your responsibilities include:

• Lead Quality function for product development teams within the BSC Quality System to develop new Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Lead Risk Management processes for new products with key inputs from cross-functional product development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
• Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
• Responsible for collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Builds quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

what we're looking for in you:

Required Qualifications

• B.Sc in Biomedical, Electrical Engineering or equivalent.
• 10 years of medical device engineering experience, with experience inMedical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the verification and validation of Capital Equipment, including hardware, software, firmware, and systems of systems interdependencies.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Demonstrated ability to mentor and coach others in analysis and risk based decision-making processes to balance business and compliance needs.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and/or systems integration

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:As an Anaplan Model Builder, you will partner with stakeholders to design and build innovative Sales Performance Management (SPM) solutions customized to meet business needs. This role will lead implementations, coach stakeholders on best practices, and ensure long-term scalability of Anaplan solutions. The ideal candidate will balance competing priorities, including model building, leading new initiatives, and supporting updates or issue resolution in existing models.

Your responsibilities will include:

• Partner closely with divisional compensation teams and the Sales Compensation team to build and optimize Anaplan solutions that support business needs.
• Support existing Anaplan models by enhancing functionality, adding new capabilities, and providing timely error resolution.
• Contribute to the long-term Anaplan roadmap for Boston Scientific, extending connected planning capabilities across Sales Incentive Compensation, Quota Setting, Territory Management/Optimization, Headcount Planning, and Compensation Modeling.
• Collaborate with IT, business applications, and business units to streamline data flows and identify opportunities for automation and efficiency.
• Enhance reporting and analytics capabilities to deliver deeper insights from existing models.
• Identify opportunities for business process improvements and establish effective, efficient practices.
• Provide training and share Anaplan Model Building best practices with divisional compensation analysts to ensure the tool is leveraged to its full potential.
• Communicate task status clearly and manage project timelines and action items effectively.

Qualifications:

Required qualifications:

• Bachelor’s degree.
• Minimum of 3 years' experience in Sales Operations, Finance, or a closely related function.
• Minimum of 3 years' experience with Anaplan Model Building; Level 2 or higher certification highly preferred.
• Experience with sales compensation and commissions processes preferred.
• Ability to quickly learn new technology and deliver meaningful results.
• Strong math skills and business acumen with a logic-based approach to solving complex problems.
• Expert-level Excel skills.
• Excellent strategic thinking capabilities with the ability to synthesize large amounts of information and logically structure deliverables.
• Experience with reporting visualization tools (e.g., Tableau) preferred.
• Experience working with sales compensation solutions such as Anaplan.
• Familiarity with MS Access, Salesforce, SQL, and other programming tools preferred.

Preferred qualifications:

• Experience with data integration tools (e.g., Informatica, MuleSoft, Boomi).
• Experience with data warehouses and intermediate data lakes (e.g., Snowflake, Databricks, Google BigQuery, S3).
• Curious mindset with a strong interest in data accuracy.
• Can-do attitude with attention to detail, precision, and continuous learning.
• Excellent interpersonal and communication skills to collaborate effectively across levels of the organization.
• Strong organizational skills and the ability to manage confidential work with discretion.
• Ability to work independently and collaboratively in a fast-paced, matrix environment, prioritize tasks, and meet tight deadlines.

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.

This is more than a role. It’s a movement.

🌿Carbon Neutrality by 2030Be the architect of our transformation as we drive our major manufacturing and distribution centers toward carbon neutrality—setting a new standard for sustainable innovation.

♻️Design and execute a global zero waste roadmap by 2030, embedding circularity into every layer of our operations.

Who You Are:

• A visionary EHS leader with a track record of driving change across complex global organizations.
• A collaborator, innovator, and strategist who sees challenges as opportunities.
• A purpose-driven professional ready to leave a legacy of impact.

Because here, your work saves lives—and your leadership shapes the future. You’ll join a company that’s committed to doing what’s right for patients, employees, and the planet. And you’ll be part of a team that’s not just talking about change—we’re making it happen.

The position requires strategic vision and hands-on implementation to build world-class EHS performance based on a strong global culture. They work closely with various functions, facilities and geographies to develop, implement and sustain EHS programs, policies and procedures that deliver the required high performance. Such strategies and programs are developed in harmony with the Companies business objectives and are aligned with its growth trajectory. The Snr. EHS Director is responsible for EHS performance at over 20 manufacturing sites and more that 120 commercial locations with a workforce of circa. 60,000. Working closely with a network of 200 EHS and Occupational Health professionals they deliver a vital two-way connection between senior leadership and site operations.

Strategic Leadership:

• Partners with key senior leadership within BSC to ensure EHS strategies are aligned with business needs and EHS challenges are communicated upwards.
• Delivers strong leadership within the EHS community across all geographical regions establishing common purpose and focus on key performance.
• Exhibits the leadership qualities of trust, integrity, courage, clear communication and loyalty in all personal actions and ensures they are fostered in the broader EHS community.
• Ensures visible and impactful EHS leadership to the broader business stakeholders.
• Understands the leadership challenges of others to facilitate the necessary partnerships for effective EHS management.
• Builds and develops an EHS staff that has the skills, competencies and abilities to meet the current and future needs of the Company at both a global and local level.

Strategy and AOP:

• Develops a Global EHS strategy that delivers the required EHS performance while supporting the company business needs.
• Ensure Global strategy is cascaded into all levels of the organization, is embedded in local strategies and monitored to ensure effective delivery.
• Create and maintain a process for local EHS issues and challenges to be communicated to Global EHS, enabling their inclusion in the global strategies where necessary.
• Achieve senior leadership agreement with the EHS strategy to drive successful outcomes.
• Envisions potential challenges 5 to 10 years out and builds protective strategies, processes and structures to protect the business and enable its continued unhindered development.

EHS Operational Excellence:

• Ensures compliance to the Global EHS policy and enhances implementation by providing core operational guidance for all the locations and regions.
• Ensures all manufacturing and Tier I Distribution locations are certified to ISO14001: Environmental Management Standard and the ISO45001: Health and Safety management standard.
• Identifies and ensures the development of Global Standards for key EHS programs, oversees their deployment and ensures verification of effectiveness.
• Delivers and maintains EHS digital platforms that enables global connectivity across all key programs, communicates real-time performance and enables early flagging of emerging challenges.
• Deliver impactful risk control and risk mitigation through structures risk analysis and problem-solving techniques.
• Ensures EHS risk-informed strategies are in place for key operational aspects, spanning Global Supply Chain, Commercial activities and Acquisitions & Integrations.

Compliance Assurance:

• Ensures the Company is aware of, and compliant to, all EHS regulatory requirements at local, regional and global level by maintaining an effective compliance assurance program.
• Delivers surveillance of pending EHS regulations, globally, regionally and locally, which enables early response. Maintains the company EHS compliant while ensuring the Company business needs are advocated for.
• Represents the Company within relevant trade associations, professional bodies and industry groupings on EHS topics relevant to the Company.

Occupational Health:

• Oversees a Global Occupational Health service that focuses on employee health, medical accommodations, return to work and employee wellness; supporting both the employee and the business.
• Ensures occupational health support services are available for all employees globally and emergency advice contacts are in place.
• Ensure the development and upskilling of the global Occupational Health Nurses is supported to maintain required competencies as new requirements emerge.

Performance:

• Establishes key EHS performance targets for Environment, Health and Safety across the entire organization that drive meaningful continuous improvement while aligned to the needs and abilities of the business, both globally and locally.
• Maintains a live tracking and reporting process for delivery of the agreed EHS performance targets with escalation and reaction mechanisms where needed.
• Ensures positive performances are recognized and celebrated.
• Establishes a positive EHS performance culture where delivery of EHS goals, both within the function and across other functions, is the norm.

Acquisitions and Integrations:

• Ensures availability and provision of EHS supports to Acquisition and Integration teams for Due Diligence, EHS Criticality assessments, gap assessments, integration plans and resourcing planning.
• Ensures acquisition Integrations are supported and actively facilitated as they adapt to the new BSC culture, programs and operational requirements.

Required Qualifications:

• Bachelor’s degree required preferably within Environmental Sciences or in an engineering discipline.
• 10+years of EH&S experience to include standard concepts, practices, and procedures within the EH&S field.
• 5+ years of people leadership experience, ability to guide, coach, direct, and develop direct reports, and drive those practices throughout their organization.
• Experience in controlling the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
• Proven ability to work through other functions and personnel to deliver on EHS goals while supporting the business locally and globally.
• Demonstrated experience collaborating with global business partners, building inclusive partnerships and valuing diversity across cultures and regions.
• Strong communication and presentation skills required, with ability to influence and drive new ideas at the executive level.
• Self-starter with high degree of latitude is required.
• This role requires travel domestic and international to BSC global locations.

Preferred Qualifications:

• MS or MBA preferred
• Global, multi-site experience is strongly preferred
• Medical Devices industry experience

Maximum Salary: $ 327800

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.