דרושים Principal Human Factors Engineer - Electrophysiology ב-Boston Scientific ב-ארהב

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.

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.

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

Visa sponsorship:

This position will start off at our Minnetonka, MN facility but will be transferred to our Weaver Lake campus Maple Grove, MN facility in 2026.

Your responsibilities will include:

• Be a part of an extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports departmental, functional, and divisional design quality goals and priorities.
• Executes methodologies to effectively meet individual and team objectives.
• Utilizes methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.
• Ensures adherence to the quality system Policies, SOPs, and work instructions following Boston Scientific’s Product Life Cycle Process (PLCP).

Required qualifications:

• Bachelor of Science in Mechanical / Biomedical Engineering or related discipline in the sciences.
• Minimum of 2+ years experience in Design Quality Assurance, related experience in quality engineering or NPD design within a regulated industry
• Understanding of Quality tools and methodologies with an emphasis on Design Controls, Root Cause Analysis and Risk Management.
• Strong communication skills (verbal & written)
• Ability to work independently and as part of a team.
• Comfortable with complaint data reviews and interpretation
• Ability to travel up to 10%.

Preferred qualifications:

• Experience with pharmaceutical or combination medical device development
• Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability).
• Experience with medical device development for single use device
• Experience with Electronic Medical Equipment.

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.

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: