Sr Quality Systems Engineer- Global Design Controls & Labeling jobs at Boston Scientific in United States, Marlborough

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

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.

About the role:

This role requires a high-level view of the product under development and its interactions with other sub-systems within its use environment. It is critical to understand the impact that one sub-system can have on the overall system and how changes within a sub-system can propagate changes in other parts of the system.

Your responsibilities will include:

• Fully participate in and successfully contribute to project teams either as an individual contributor or technical leader
• Able to design and develop high-level system architecture.
• Develop system and subsystem-level requirements.
• Work independently to plan and schedule R&D activities necessary to meet timelines.
• Design and coordinate engineering tests and experiments.
• Perform troubleshooting on systems related to design, interactions with other sub-systems, materials, or processes.
• Summarize, analyze, and draw conclusions from test results. Be able to run basic statistical models to analyze data.
• Prepare standard reports/documentation to communicate results to the technical community.
• Responsible for engineering documentation.
• Work cooperatively with outside vendors, quality, regulatory, clinical, and marketing teams to ensure project success.

Required qualifications:

• BS/MS in Biomedical, Biomaterial, Mechanical, or Systems Engineering.
• 6+ years of engineering experience with medical devices.
• Experience with troubleshooting medical systems.
• Proven self-starter with a strong track record of technical leadership and the ability to work independently to plan, schedule, lead, and execute tasks necessary to meet project deadlines.
• Experience with systems architecture, design and development.
• Experienced in testing, system and subsystem requirements preparation, test method development, design verification, and validation.
• Hands-on approach to problem-solving.

Preferred qualifications:

• A Biomaterial Engineering background is strongly preferred.
• Medical device systems product development experience.
• Strong communication skills (verbal and written).
• Proven technical leadership of prior projects.

Maximum Salary: $ 164500

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

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

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

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

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

About the role:

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

• Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
• Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.

• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Act as the sub-process steward for the global Internal Audit process.
• Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.

• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.

• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross-functional quality initiatives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field
• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
• Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Ability to travel up to 25 - 30% domestically and internationally

Preferred qualifications:

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills

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.

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Hybrid Roles:

About the role:

Works cross-functionally to lead process development of complex technologies on new products and ensures efficient and effective transfer of new product into production.

Mechanical Design (Mechatronics-Oriented):

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Process Control & Automation:

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Process Engineering & Continuous Improvement:

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• Assess, prioritize, andon platform or derivative projects.
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May supervise Technicians and Engineersto achieve project goals.

• Additional Duties:
• Oversees development builds associated with the project using special work requests.
• Writes and reviews validation protocols and reports applicable to new processes.
• Plans, organizes, and conducts all aspects of technical reviews.
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Contributes ideas to or generates Intellectual Property submissions.
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• May serve as a core team member or extended team member on new product projects.

Minimum Requirements

• Bachelor’s or Master’s Degree in Mechatronics Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
• 7+ years of experience in process engineering, mechanical design, and control system integration in a manufacturing or industrial automation setting.
• Proven experience in:

1. 3D mechanical CAD tools (e.g., SolidWorks, PTC Creo, AutoCAD)
2. PLC/HMI development (e.g., Siemens TIA Portal, Allen-Bradley RSLogix/Studio 5000)
3. Motion control systems (e.g., servo drives, stepper motors, pneumatics)
4. Control systems programming, electrical panel layout, and troubleshooting.
5. Strong understanding of mechatronic system integration—including mechanical, electrical, and software interfaces.
6. Familiar with robotics, machine vision, and industrial communication protocols.
7. Experience with process documentation (P&IDs, control narratives, wiring diagrams).
8. Ability to lead cross-functional teams and drive projects from concept to production.

Preferred Qualifications:

• Experience with MATLAB/Simulink or other modeling/simulation tools.
• Familiarity with NI LabVIEW, Python, or C/C++ for custom test or automation tools.
• Experience in regulated industries (medical device, automotive, aerospace, or semiconductor).
• Professional Engineer (PE) license or relevant certifications (e.g., Six Sigma Black Belt).
• Knowledge of Industry 4.0, IoT-enabled manufacturing, and digital twin technologies.

Your responsibilities will include:

• Assist in execution of proactive regional plan that involves clinical, sales, and service support to improve market share and increase quality of service to customers.
• Serves as primary resource for clinical support in the areas of case coverage, basic troubleshooting, specialty product usage and customer training.
• Attends cases in customer accounts and advises physicians on clinical attributes / techniques associated with our coronary products. Represents Interventional Solutions field organization during designated BSC clinic lab days.
• Educates customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms. Provide supplemental training support during product launches and for high touch specialty products (filter wire /rotablator).
• Responds to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel to develop optimal solutions (especially training, troubleshooting and general case support for iLab hardware / IVUS).
• Responsible for consignment inventory tracking, semiannual audits, expired product and returns.
• Ensure timely collection, reporting of all required medical documentation pertaining to our procedural device operation.
• Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.
• Must live within the assigned geographical territory.

Required qualifications

• BA/BS required or equivalent work experience.
• Minimum of 2 years of relevant experience in sales, healthcare industry, or clinical setting.
• Must have a technical aptitude; be able to discuss & explain complex technical product information.
• Must be able to work flexible hours and travel when needed.
• Strong business acumen and strategic problem-solving skills.
• Ability to interact effectively with internal and external customers (including all BSC divisions).

Preferred qualifications

• Clinical work experience in Cardiology within the medical device and/or pharmaceutical industry (clinical, sales).

• Prior experience supporting interventional cardiology procedures in a catheterization lab or hybrid OR environment
• Demonstrated success in a customer-facing field role within a medical device company, with a focus on cardiovascular or interventional solutions
• Familiarity with intravascular imaging technologies (e.g., IVUS, iLab) and atherectomy systems (e.g., Rotablator)
• Strong presentation and training skills, with experience delivering product education to physicians, nurses, and lab staff

The anticipated annualized base amount or range for this full time position will be$65,000 to $85,000, 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.

Your responsibilities include:

• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Oversees the Design Controls and Risk Management aspects of Design History File, mitigate risks and ensure compliance with applicable regulatory standards during New Product Development.
• Translate strategy into action by converting broader organizational goals into specific objectives and tactical plans for the Quality Engineering team. Key focuses include New Product Development projects and goals, complaint reduction, value improvement and product performance challenges.
• Owns and drives commercial product monitoring and all related product sustainment activities including complaint signal management, CAPA and management of regulator responses.
• Communicate effectively. Interacts with and influences stakeholders at all levels of the organization, presenting complex challenges in clear and actionable manner.
• Act as a champion for quality disciplines, decisions, and practices. Lead in guiding team direction and execution of product and divisional programs. Promote accountability and a proactive mindset toward excellence.
• Provides guidance and leadership to team of direct reports on workload management, priorities, and project execution. Provides mentorship in quality technology, quality principles and overall regulation, risk management and design control concepts.
• Continuously develops direct reports through individual development planning processes.
• Determines appropriate staff levels and schedules. Works with key partners to understand priorities and plans resource allocation accordingly.
• Assures activities and deliverables in area of responsibility meet regulatory and corporate requirements.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Directly interfaces with internal and external audit activities including direct audit support locally and at several international manufacturing sites.
• Partners with internal and external stakeholders and vendors to ensure quality objectives are met and to provide solutions to quality issues.

Required Qualifications

• Minimum of a bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study
• Minimum of 8 years of related work experience in Design Quality or an equivalent combination of education and work experience
• Minimum of 3 years of direct or indirect supervisory experience with a passion for leadership and team development
• Medical Device or regulated industry experience
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls, risk management and design optimization
• Ability to travel up to 10% (Domestic and International)

Preferred qualifications

• Advanced degree in technical field or business
• Experience leading technical teams
• Strong strategic and critical thinking capabilities with the ability to balance long-term vision with executional excellence
• Excellent collaboration, communication, and interpersonal skills with the ability to work across cultures and geographies
• Ability to drive change in a matrixed, global organization
• Experience with problem solving including Six Sigma Certification(s)
• Strong communication skills (verbal & written) in a technical environment

Maximum Salary: $ 243000

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.