דרושים Quality Technician - 2nd Shift 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.

About the role:

This role will require collaboration with engineering, production, and quality teams to identify and resolve equipment malfunction related issues.

Your responsibilities will include:

• Identify and fix problems that arise during the braiding process in a quick and effective manner to minimize downtime
• Perform routine maintenance and document the details in the machine maintenance system in compliance with the Quality System
• Monitor processes and perform adjustments to ensure product quality
• Evaluates and orders necessary equipment, tools and fixtures.
• Revise existing documents, processes, and/or methods to correct or improve processes/product
• Ability to handle the physical demands of the job, including moving equipment, standing for long periods, and handling materials
• Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment
• Participate in the redesign and/or development of equipment with the Process Development team to enable the integration of new products
• Contribute toward Braiding and Molding Technology Continuous Improvement initiatives to enhance performance, reduce downtime, improve overall manufacturing efficiency, and other Value Improvement Projects (VIP)

Required qualifications:

• 2 years with High School Diploma and/or equivalent experience, training, or apprenticeships

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

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:

Assist R&D engineers, scientists, and/or teams in developing and analyzing products, materials, processes, or equipment. This level of position requires an extensive knowledge base, high independence, a demonstrated ability to follow detailed instructions, and a deep aptitude for learning.

As an R&D Technician IV at Boston Scientific, you’ll be hands-on in shaping the next generation of catheter-based medical devices. In this senior role, you’ll work closely with engineers and cross-functional teams to build prototypes, run tests, and solve technical challenges that directly impact patient care. You’ll have the independence to drive your own work while contributing to a culture of innovation and collaboration.

Your responsibilities will include:

Execute assigned tasks for project deliverables.

Develop solutions and contribute to initial design, testing, and process concepts.

Construct prototype products and/or detailed test methods and fixtures from concepts.

Organize, coordinate, execute, and document testing of prototypes/materials with minimal engineering guidance.

Develop new test methods and/or make revisions to existing test methods.

Coordinate procuring and qualification of new or modified test equipment.

Work with internal resources and external vendors to identify and obtain supplies and services.

Contribute to problem-solving and root cause investigations (DOE, FMEA, CAPA)

Train/Coach peers on their job's technical aspects, including interpreting and rationalizing results (i.e., statistics, DOE).

Required qualifications:

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

Preferred qualifications:

• 5 years of similar experience
• Experience with complex catheter design, assembly, prototyping, and testing
• Experience with electromechanical products and test systems
• Medical device test method and fixture development experience
• Strong organizational skills and self-motivation
• Strong track record handling detailed oriented work

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.

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.

The primary focus is to build a quality product by following processes to meet all production goals.

Your responsibilities will include:

• Understands and adheres to safety policies and practices.
• Responsible for quality and adheres to manufacturing process requirements, the Boston Scientific Corporation Quality Policy, and the Strategic Quality Process (SQP).
• Builds product by following all processes in which certified (in their most current revision), and completes other assigned work, while meeting manufacturing goals and metrics.
• Gains a basic understanding of Lean Manufacturing and related principles.
• Willing to flex and rotate as necessary and work well with all group members, both within the team and cross-functionally.
• Under the direction of other maintains accurate records such as Shop Floor Paperwork (SFP), training Records System (TRS), Product Data Management (PDM), Systems Application & Products (SAP), and Process Equipment Optimization (PEO).
• Moderate mechanical aptitude. Able to learn how to set up equipment to meet process specifications.
• Under the direction of others interprets quality specifications via SPC; understands tight tolerancing through the use of various measurement equipment.
• Assist and learn to take ownership and accountability to drive metrics by actively participating in Focused Factory cross-functional teams.
• Understands and follows all BSC and site-specific policies and procedures.
• Responsible for attending and passing all core required BSC and site-specific training (i.e. QS Basics, RTK, Lean Training, Extrusion 101).
• Demonstrate an understanding of the basic functions of SAP.
• Able to perform basic extrusion troubleshooting methods.
• Learns to plan and prepare the equipment to meet the customer’s requirements.
• Provide CI suggestions.
  

Required qualifications:

• 2 years of experience with a High school diploma/degree/equivalent, or equivalent work/education experience

Preferred qualifications:

• Previous machine operation experience / mechanical minded preferred