Supplier Quality Engineer Ii - Endoscopy Sfmd jobs at Boston Scientific in United States, Marlborough

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:

• Responsible for planning facilities equipment layouts for economy of operation and maximum utilization of facilities and equipment.
• Reviews and estimates design costs including equipment, installation, labor, materials, preparation, and other related costs.
• Develops criteria and performance specifications for facilities infrastructure and equipment required to meet unique operating requirements and building/safety codes.
• Developing and driving new process changes to improve efficiency and compliance
• Coordinates with architecture/engineering firms in developing design criteria and preparing layout and detail drawings.
• Manages commissioning and qualification of controlled environment areas and bulk systems used in the manufacturing of medical devices
• Achieve detailed mechanical understanding of all infrastructure supporting medical device manufacturing and lab areas.
• Prepares bid sheets and contracts for construction projects supporting competitive bid process.
• Effectively collaborate cross-functionally to provide project recommendations for diverse groups of customers.
• Effectively manage construction projects to tight timelines and costs
• Inspects or directs the inspection of construction and installation progress to ensure conformance to established drawings, specifications, and schedules.
• Gathers and reviews data concerning facility or equipment specifications, company or government restrictions, required completion date, and construction feasibility.
• May be responsible for scheduling, coordinating, and planning preventative maintenance.
• Plans and coordinates shutdown of manufacturing areas for updates, modifications, and critical maintenance
• Responsible ensuring quality compliance of controlled areas and systems in alignment with FDA regulations, global standards, site processes, and industry standards
• Create systematic decision assessments ranging from high-level budgetary reviews to detailed design reviews

Required qualifications:

• Bachelor’s degree in engineering or a related field
• 3+ years of experience in facilities engineering or a related discipline
• A proactive, self-driven approach to work and learning
• Demonstrated ability to lead, inspire, and support others
• Strong communication skills—both written and verbal
• Collaborative mindset with the ability to work across diverse teams and disciplines
• Experience navigating large, cross-functional organizations
• Ability to travel up to 20% of the time (project-dependent)
  

Preferred qualifications:

• Experience leading or coordinating complex engineering design projects
• Ability to translate technical concepts into clear, accessible language
• Background working within large-scale or Fortune 500 organizations
• Familiarity with qualifying infrastructure for regulated manufacturing environments (e.g., medical devices)
• Exposure to lean manufacturing principles and continuous improvement practices
• Experience guiding or supporting process transformation initiatives
• Adaptable and resilient in dynamic, evolving environments

Maximum Salary: $ 132000

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.

Costa Rica-Coyol

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.

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Process Engineering & Continuous Improvement:

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• 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 will include:

• Create/maintain accurate data entry into the complaint management system for inspected returned product.
• Returned product decontamination and route products to Complaint Investigation Site (CIS) labs.
• Review and process returned paperwork.
• Returned product retention including physical archival, maintaining accurate archive records, and product scrap.
• Respond to internal and external customer queries concerning product location, credit, or special needs or procedure changes relating to product processing.
• Understand and adhere to general safety practices, departmental process requirements and the Boston Scientific Corporation Quality Policy.
• May be responsible for SAP transactions and correct SAP error log reports.
• May perform routine laboratory testing in accordance with established procedures for returned products. Document analysis findings into complaint management system.
• Actively interface with other Boston Scientific departments to corroborate special needs or procedure changes for product processing.
• Participate in continuous improvement activities.

Required qualifications:

• 3 years of experience with a High School Degree or an equivalent combination of education/work experience

Preferred qualifications:

• 1 year of relevant experience (data entry, shipping/receiving, decontamination, or other post-market experience)
• Degree in engineering or a science-related field

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.

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.

Spencer Gregory Hale

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

• Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
• Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
• Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
• Supporting internal and external audits and audit responses for existing products.
• Monitoring compliance with company policies and procedures.
• Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

• Bachelor's degree in Science, Health, or Engineering.
• Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
• Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

• Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
• Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
• Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

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.