Service Quality Engineer Ii jobs at Boston Scientific

About the Role:

In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

Your Responsibilities Include:

• Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
• Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
• Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
• Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
• Provide task direction, coaching, and mentorship for technician team members.
• Participate in team decision-making and display team problem-solving/communication skills.

What We’re Looking For:Required Qualifications:

• Bachelor’s degree in engineering, technology, mathematics, or related science
• 2+ years of relevant experience in a regulated industry
• Strong verbal and written communications skills; Good documentation practices
• Works effectively in a Controlled Environment Area (CEA) manufacturing environment
• Self-starter with a proven ability to successfully work with minimal supervision
• Knowledge of basic Quality Management Systems
• Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Preferred Qualifications:

• Medical device experience
• Comfortable with utilizing analytical equipment (including microscopes)
• Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
• Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
• Experience running/owning nonconforming event risk assessments and investigations
• Proficient using manufacturing control software (various MES, MasterControl, etc.)
• Project management experience

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.

Your responsibilities include:

• Perform all aspects of the monthly financial close including generation of monthly and quarterly management reporting and variance/trend analysis
• Supports the annual planning process for the functional areas of responsibility including coordinating with the various functional groups to develop operating expense budgets and providing analytical support to identify key business drivers
• Analysis and submission of functional budgets
• Support decision-making process to enable profitable growth
• Support regular and adhoc reporting and presentations to management
• Identify and drive cost saving opportunities across the SG&A functions
• Quickly respond to numerous ad hoc queries from internal customers (including Senior Management)

Minimum Qualifications:

• Bachelor’s degree in Finance or Accounting
• 5+ years of relevant FP&A experience
• MS Excel and PowerPoint required, financial tools (Hyperion (Oracle), SAP) preferred
• Excellent oral and written communication skills
• Strong financial analysis, communication, organizational and prioritization skills
• Strong attention to detail and data accuracy

Preferred Qualifications:

• Ability to multi-task and set priorities/execute in a high-paced organization
• Ability to work in a dynamic environment, adhere to tight deadlines
• Team orientated
• Must have a process improvement mindset and strong problem-solving 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.

Your responsibilities will include:

• Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
• Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
• Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.

• Self-motivated with a passion for solving problems and a bias for action.

• Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
• Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
• Collaborate in planning of software verification and validation strategies.
• Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
• Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
• Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
• Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
• Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
• Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
• Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.

What we’re looking for in you:

Required qualifications

• Bachelor’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 5+ years of experience in cybersecurity engineering, with a focus on product development and risk management or Master’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 3+ years of experience in cybersecurity engineering, with a focus on product development and risk management
• Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
• Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
• In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
• Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
• Strong leadership, decision-making, and team-building capabilities.
• Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
• Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.

Preferred qualifications

• 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
• Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
• Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
• Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
• Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
• Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
• Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.

Maximum Salary: $ 156900

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

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

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

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

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

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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

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

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

Your Responsibilities will Include:

• Produce high quality products, safely, on time for the customer at the lowest cost
• Facilitate and partner with a cross functional production team of production, quality and manufacturing engineering team members to achieve annual safety, quality, service and cost goals while maintaining a high engagement & high-performance culture
• Identify customer requirements to deliver the right products at the right time
• Be responsive & flexible to customer demands
• Achieve & exceed product cost goals
• Support new product development readiness activities for the line team
• Manufacture products to the highest quality standards and ensure compliance to all Boston Scientific policies and regulations
• Promote safety, quality & compliance among the team while maintaining Good Manufacturing Practices
• Foster teamwork and enable a culture of Operational Excellence throughout the entire cross-functional team
• Ensure effective two-way communication between the production line team and cross-functional support teams
• Manage, motivate, develop, and involve product builders through coaching and performance management
• Embed the company values through demonstration & recognition of individual & team behaviors
• Utilize production area planning tools to ensure all resources are in place to achieve team commitments such as Direct Labor Staffing, Equipment Capacity, Support Team, and Space
• Ensure product builder training is effective & efficient and maintain training versatility across entire team
• Utilize leader standard work to ensure lines are meeting standards and escalate appropriately
• Lead & create team engagement around continuous improvement goals for safety, quality, service, cost and space through the utilization of lean and operational excellence tools and best practices
• Benchmark and share best practices
• Partner with materials management team for build planning and material delivery systems and tools
• Analyze build plan requirements and provide forward looking monthly production commitments
• Anticipate requirements and position resources to meet & exceed the customer needs
• Provide appropriate input into the long-term planning of the production area

Required Qualifications:

• Bachelor’s Degree or equivalent combination of education and experience will be considered in lieu of degree
• Manufacturing or engineering experience
• Solid computer skills required including Microsoft Excel, Word, and PowerPoint
• Demonstrated Lean tools/systems experience
• Able to support and lead a production team working 2nd shift hours (1:30 PM – 9:30 PM), Monday through Friday.
  

Preferred Qualifications:

• 3+ years of supervisor/management experience
• Experience in a regulated environment
• Medical device industry experience
• Strong written and verbal communication skills with the ability to communicate at all levels of the organization
• Ability to be flexible and agile
• Ability to be a self-starter

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.

Applicants must be authorized to work in the United States without the need for employer sponsorship, now or in the future.

• Establishing category strategies that result in a sustainable competitive advantage.
• Managing strategic supplier relationships in line with company and category expectations
• Negotiating and executing contracts that deliver the best outcomes for Boston Scientific
• Driving sustained year-over-year value improvement related to quality, service, and cost.
• Defining technology roadmaps that align with long-term product and patient needs.
• Collaborating with Supplier Engineering to develop should-cost models.
• Gathering and analyzing market intelligence to report on trends, risks, etc.
• Identifying market and sourcing risks; work with stakeholders to define and execute mitigation plans.
• Providing key data analytics and reporting to support category and supplier strategies
• Supporting the broader sourcing team with data analytics and supplier communications
• Providing source selection recommendations for new products that align with the category strategy.
• Driving early supplier involvement with R&D to achieve development objectives, timelines, and reduce costs.
• Facilitating supplier business reviews; attend on-site supplier visits for assessments, negotiations, business reviews, etc.
• Facilitating the identification and evaluation of new materials and technologies
• Identifying and rationalizing insourcing vs. outsourcing opportunities
• Supporting or leading business process improvement projects
• Providing escalation support to site purchasing teams as required

• Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
• Experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
• Proficient with MS Office Excel and other applications (i.e., Word, PowerPoint, MS Project etc.)
• Ability to travel up to 20%.

• Minimum 2 years of experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
• Master’s Degree or professional certification (i.e., CPSM, CPIM, CSCP, PMP, Lean Six Sigma, etc.)
• Experience sourcing for electronic components or medical devices.
• Experience working in medical device or similar regulated industry.
• Strong data analysis skills, with ability to translate data into strategy
• Ability to take direction and coaching from mentors
• Strong decision-making and negotiation skills, ability to influence internal and external teams.
• Ability to work independently and collaborate with cross-functional teams to complete projects.
• Strong interpersonal skills, with ability to communicate effectively with individuals on all levels.
• Strong critical thinking and analytical skills: process and results-oriented
• Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively.

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.

Thailand-Bangkok; Indonesia-Jakarta; Vietnam-Ho Chi Minh

PURPOSES:

• The role is responsible for partnering with Commercial Site OSMs (Office Service Managers), Country Coordinators (CCs) and Employee/Customer Experience Leads for the support and implementation of the facility strategy, including all aspects of real estate portfolio, facilities, environment, health and safety, capital spending and expenses for Boston Scientific in Boston Scientific’s Growth Markets including sites in India, and the ASEAN Countries (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines)
• The role directly reports to the Senior Manager, APAC Regional Real Estate, EHS
• The role is instrumental in coordinating with diverse stakeholders to support Growth Markets commercial real estate assets, supporting its business objectives, minimizing costs, and providing innovative, efficient, and safe working environments for employees.
• Dedicated to providing facilities that adhere to our global standards and are cost-effective, safe, and valued by Growth Markets organization and employees.

Real Estate:

• Develop and submit the Growth Markets GFMP submission and strategy.
• Manage EH&S initiatives including environmental, health, safety, and security performance initiatives
• Track Site Master Plans (SMP) in Growth Markets, of associated real estate and facilities projects (acquisitions, dispositions, renovations, etc.) in support of the GFMP.
• Evaluate capacity and space utilization at each site through data analysis and communication with appropriate departments and build reports that accurately project future population which input into SMP.
• Tracking of all site leases, ensuring leases for existing and new sites meet BSC objectives and budget and alignment with Global GREFAC for lease management.
• Proactively address lease and contract management including but not limited to; negotiating and managing leases for owned and leased properties, ensuring compliance with lease terms, tracking lease renewals; proposing strategic lease renewals, negotiations and/or terminations.
• Oversee real estate development, acquisition, and disposition in accordance with organizational guidelines and expectations.

Workplace Strategy

• Leverages workplace strategy with input from other functions to promote employee productivity, well-being, and collaboration
• Ensuring all projects are carried out in accordance with the latest BSC Global Design Guidelines
• Leverages space utilization metrics to make informed real estate decisions
• Responsible for VIPs associated to country projects

Capital Projects:

• Proactively reviews Facilities capital budget including partnering with Finance to track actuals, accruals, and variances
• Creates and manages process for cost code alignment
• Adheres to capital request process including CERA execution
• Develops and implements start-up and relocation plans for new facilities and directs projects and renovations of existing facilities as needed.

Facilities Operations:

• Responsible for vendor and contract management for regionally executed projects
• Aligns with Sr. Manager on Soft Services process and supports inputs needed from countries
• Manages in-country “Wheel of Spend” and ensure adherence to BSC standardized costs codes and operational expense reporting
• Act as a liaison with major service contractors, utility contacts, and outsourced vendors.
• Sets priorities, performs forecasting, and allocates the resources needed to complete all preventative and corrective maintenance tasks.

Environment:

• Coordinates with Sr. Manager and Global Green Team to gather all Environment related metrics (i.e. energy, fleet, etc)
• Develops local sustainability programs including metrics and reporting
• Establish/Manages country specific environmental compliance registers, completion of annual regulatory assessments, and creation of improvement plans for any gaps identified
• Responsible for driving compliance and ensuring completion of any mandatory environmental reporting/programs required in the region
• Support Green Team Initiatives

Health & Safety:

• Facilitate the establishment of all Growth Market Health and Safety compliance registers, completion of annual regulatory assessments, and creation of improvement plans for any gaps identified.
• Ensure adequate emergency response plans are in place at all sites and adequate training and drills are in place
• Ensure health and safety risk assessments are completed for all office and field-based employees, programs are in please to address any high-risk findings. Assessments and action planning are to be captured in Cority.
• Ensure regulatory/BSC required employee exposure controls and monitoring programs are in place in the countries to protect employees, such as PPE, radiation badging, bloodborne pathogen protections.
• Ensure all health and safety regulatory reporting, such as incidents, accidents, prescribed diseases are reported to the required authorities.
• Ensure scheduled delivery of required EHS incident reporting and metrics to Global EHS using Cority.

REQUIREMENTS:

• Relevant experience in facilities management.
• Relevant experience and proven results in project management and budget management
• Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
• Ability to work independently, highly organized, and self-driven
• Excellent MS application skills (PPTX, Excel, Word, Project, Teams)
• Excellent communication and business in both verbal and written English.
• Bachelor’s degree in relevant field or 8-10 years of industry experience