תוצאות חיפוש - Biosense Webster

A great opportunity to join the finance department of a Global Medical device leading company as a cost accounting analyst. This person should be super diligent, and data oriented.

Description:
• Managing financial aspects of the company's inventory
• Responsibility for the monthly, quarterly, and annual closing process
• Prepare and monitor the annual business plan and forecasts for inventory
• Work closely with accounting and tax team and support annual audits
• Prepare and maintain inventory reserves (SLOB, FAA etc.)
• Act as a finance business partner for global supply chain teams
• Perform inventory controls and ensure compliance with company's policies and procedures.
• Support ad hoc requests/ projects
• Keep continuous improvement mindset to simplify process and automation oriented

A great opportunity to join the finance department of a Global Medical device leading company as a Financial Analyst.

• Supporting monthly, quarterly, and annual closing process.
• Review and approval of Payments.
• Hedge accounting and preparation of hedge forecasts.
• Responsible for preparing Tax Reports and reporting to authorities.
• Performing SOX controls.
• Supporting annual financial statements.
• Keep continuous improvement mindset to simplify process and automation oriented.

Biosense Webster is recruiting for a NPD Quality Manager, located in Haifa, Israel.
NPD Quality Managers are responsible for leading the QA team supporting the design and development of new products in compliance with Biosense Websters Quality System. This role executes quality and business strategy for our new products, collaborating closely with global sites in identifying and implementing design and manufacturing solutions, ensuring effective and timely product launches.
Biosense Webster's new product development teams realize our future success in delivering innovative effective medical devices to achieve successful outcomes in the treatment of cardiac arrhythmia.
Key Responsibilities:
• Lead QA Project Team members on key product design development activities.
• Participate on multi disciplined design development teams as the Quality and Compliance representative, partnering, interacting and providing input to groups such as, R&D, Software Development, Regulatory, Manufacturing, Marketing, and Product Managers.
• Communicating and partnering with external development and manufacturing partners, relative to GMP issues, project plans, due dates, problem identification and resolution.
• Ensure compliance with Health Software and Design Control requirements for Medical Devices and Medical Device software. Lead and contribute to the generation of our products risk management file
• Serve as a representative on Design Review Committees, including as an independent reviewer.
• Monitoring of data applicable to product development and timely communication of quality, project and/or business related issues or opportunities to next management level.

Escalation and Standards Quality Lead
Under NPD Quality & Compliance Manager and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Compliance with Standards

• Responsible for implementing Quality & Compliance processes and Standards for products (including External and Internal J&J standards and processes) and leads related activities
• Participate in quarterly Global Standards Council and review reports, and lead R&D Council assessments for inclusion of tracking specific standards in the Standards and Regulations Management Meetings
• Lead and manage Standards and Regulations Management Meetings
• Facilitate and follow up on Gap assessments of External and J&J standards Notifies SMEs about new standards or updated revisions and initiates related activities
• Follow up with SMEs and drive standards compliance to completion
• Maintain Standards and Regulations Management SOP and list of applicable standards
• Performs as SME and provides guidance and support in matters related to standards during Quality Audits, CAPA investigations, and technical documentation updates
• Provides quality inputs to the NPD Quality & Compliance (Quality Plan) and Project teams (CTQ)
• Develop and explore methodologies and deploy reliability and quality measures in NPD

Escalation of Quality and Regulatory Compliance Issues

• Monitoring signals of a potential escalation for Product Safety, Quality, or Regulatory & Compliance issues (complaints, defects, early triggers etc.)
• Report potential or confirmed Product Quality Issues or Regulatory & Compliance events to the appropriate Quality and Compliance organization for evaluation for escalation, notify Escalation Team
• Leads failure investigations and escalation of product issues: collect data (failure analysis, product affected, complaints analysis, risk assessment, etc.) and coordinates investigation associated with the product issue under review in order to define the problem to be evaluated
• Collaborate with cross-functional internal and external teams: Quality, RA, R&D, Clinical, MSO, etc.

Biosense Webster Israel is recruiting for Software Complaint Analyst in the R&D Group, located in Yoqneam, Israel
The Software Complaint Analyst will play a pivot role in investigating customer complaints on the company medical device product, originating in potential software defects, acting between the Customer Complaint QA department and the R&D Software department.
Key Responsibilities:
• Reception of customer complaints on the Medical Devices of the company, those assigned for R&D software investigation (when potential root cause is a software bug)
• Preliminary software investigation of the complaint, using software debugging tools (crash dump and log analysis, step by step defect reproducing etc.)
• Routing of complaint to appropriate R&D software developer for further handling
• Leading the contact with the global field support teams for complaint data fetching
• Participation in the Quality Assurance company meetings for complaint handling and trending analysis
• Software Complaint weekly internal reports - writing and sending
• Initiate continuous improvement actions in the software complaint management process, the company software maintainability and serviceability, by a continuous mutual learning dialogue with the software developers.
• Sharing and presentations of interesting and teaching complaint cases with the software department

In this role you will have the opportunity to take part in the development process of innovative technologies, which improve the quality of care for arrhythmia patients worldwide
We offer you a chance to develop in a challenging role while your studies and a chance to learn and be inspired by professionals in this field.
Key Responsibilities:
In our company, the Automated SW Testing Student role is to ensure that the medical devices and stand-alone software systems, meet their requirements, intended use, and high-quality level.
• Develop, review and execute automated scripts and tools, and document test results
• Perform product testing and defect management throughout the Software Development Lifecycle
• Provide timely and meaningful feedback on the product to the development team
• Plan and design STD documents ensuring that they meet requirements and standards
• Drive innovation; promote knowledge and use of new tools
• Contribute to the company’s team-work and culture

Biosense Webster Israel is recruiting for a DevSecOps Technical Leader, located in Yoqneam - Israel.
The DevSecOps Technical Leader will lead the R&D team composed of 2 Azure DevOps Server experts, and two Computing Platform Engineers, to maintain and develop the central company Azure DevOps server (hundreds of users), and to contribute to the main company Medical Device design in the areas of Operating System Image Design (Windows), software product installation solutions, and product cybersecurity control implementation.

Key Responsibilities:
• DevSecOps Application Lifecycle management - leading the team and its vision
• Task management of the DevSecOps team members
• Technical mentoring of the DevSecOps team members
• Leading the contact with other company groups: Software Development, Field Support, Sustained Engineering, IT (local and J&J Global)

The Production QC Specialist is responsible for QC activities in production related to goods to be shipped, verifying production lines quality standards compliance, supplier’s guidance with Biosense's needs and requirements such as Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), calibration support, and quality requirements (visual inspection support).

We are looking for an excellent, highly motivated, and experienced Technical Sourcer to join our Talent Acquisition team.

As a Sourcer, you will be part of the Johnson & Johnson Talent Acquisition team in Israel and play a key role in working with recruiters and hiring managers across the board.
You will lead the development of sourcing strategies to identify and attract talents to our growing businesses and demonstrate creative ways to build a candidates' pipeline.

Role's responsibilities
• Source, engage, and attract top talent to technical and other professional critical roles
• Proactively build passive and active candidate pipelines to meet recruitment current and future needs
• Partner with recruiters to create an effective search strategy to fill open positions
• Ability to focus on multiple requisitions, prioritize sourcing channels/activities, and exhibit on-time delivery commitment.
• Partner with recruiters and the business to develop a diverse candidate pipeline
• Proactively work to identify, initiate and implement recruitment sources, including – academy relations, alumni groups and recruitment fairs, referral program and internal campaigns, sourcing platforms (such as LinkedIn Recruiter, Facebook, Github, etc.,) meetups, and conferences
• Share our company's value proposition to increase and strengthen brand awareness in the market

Biosense Webster Israel is recruiting a Software Integration & Testing Engineer, for the R&D group of our company located in Yoqneam-Israel.
Our Software Integration & Testing Engineer plays a meaningful role in ensuring the software quality of the medical devices at an early stages of the product lifecycle. As a member of the R&D group, you will design tests of the new features under development, perform them and detect potential defects in a tight and daily collaboration with software developers.
KEY RESPONSIBILITIES:
- Test the new software features and their integration to the medical device
- work side-by-side with software developers in short software development, debugging and re-testing cycles
- Perform software regression performance tests
- Design and implement software tests using a free, exploratory and agile approach.
- Document and communicate potential bugs detected by testing
- Learn new feature software by attending design reviews
- Write and release the official SW Integration & Testing Plans and Reports for major release versions

A Fact: 10% of the older population will suffer from heart rhythm disorder.
You can become an expert in the mission of improving their lives!
Are you interested to learn and be mentored by our experienced software engineers?
This is an exciting opportunity to work with highly talented people on one of the most cutting-edge technologies.

The Cloud DevOps SecOps duty and responsibility is to:
1. Perform required operation for Cloud Solution operation.
2. Write the code (typically scripts) that will: Install, Upgrade, Solve Cybersecurity and Privacy issue, improve solution performance.
3. monitor the operation of the solution including cybersecurity issues and performance issues.
4. Document all his work in Azure DevOps (ADO)
5. Be involved in the design of the solution to supply optimal cybersecurity protection, operation, and performance.
6. Be involved in the solution generation pipeline, including operating static analysis and addressing the findings.
7. Be responsible for generating the procedures for his activities, and to prepare the solution for related audits, such as ISO 27001, HIPAA, HiTrust.
8. Work according to all relevant procedures.
9. Support complaints investigations.

General:
• Drive innovation; promote knowledge and use of new tools
• Responsible for communicating business related issues or opportunities
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Biosense Webster is looking for a Product Information Security Engineer.
Are you looking to elevate your cyber career? Your technical skills? Your opportunity for growth? Biosense Webster is the place for you!
As a Security Engineer, you will provide security support for several emerging technologies, advise on the design and development of secure systems architecture and inquire best practices and information systems technologies available to meet security requirements.
You’ll have the opportunity to work closely with technical stakeholders to provide guidance and recommendation regarding best practices, security controls as outlined within NIST SP 800 series and ISO, HIPAA, GDPR guidelines.
Specific functions will include, but are not limited to:
• Identify security design gaps in existing and proposed architectures and recommend changes or enhancements
• Become the security subject matter expert who can explain technical topics
• Closely working with other developers and cloud solution architects in planning, developing, and implementing security controls
• Provide security recommendations that balance business requirements with information and cybersecurity requirements
• Demonstrating Understanding of business processes, security risk management, and related standards
• Reviewing security scans (e.g., Nessus, WebInspect, Nexpose, Veracode) and communicating to stakeholders
• Create a well-informed cloud Infrastructure security automation strategy with a strong emphasis on standardization and reusability
• Implement risk management programs by utilizing NIST, RMF
• Establish security controls to ensure the protection of client systems
• Implement cutting-edge security tools

Regulatory activities:
• Leading R&D projects by Developing and Maintaining regulatory strategy for new products (NPI);
• Maintaining product compliance with Global Regulations and Standards;
• Leading product certificate renewal and new product registration Worldwide, in accordance with EU MDR, FDA, PMDA, NPDA guidelines and requirements;

General:
• Leading internal and external audits
• Leading continuous efficiency and improvement activities of existing processes

A Fact: 10% of the older population will suffer from heart rhythm disorder
You can become an expert in the mission of improving their lives!
Design and implement SW components and algorithms for Medical Device products, written in C++ and C# on a multi-threaded system.
This is an exciting opportunity to work with highly talented engineers, working on one of the most cutting-edge technologies.

We at Biosense are looking for a NPD Quality & Compliance Engineer for an innovative new project. In this role you will:
• Support R&D Design activities throughout the Product Development process
• Managing Project DHF and providing status to the Project management
• Provide quality inputs for new or modified products development
• Accountable for the Product Risk Management process throughout the PDP
• Support the Design Change process by reviewing the change and performing impact assessments with the team
• Participate and approve the Product Design Reviews
• Review and approval of the Product DHF documents
• Write, review, and implement quality procedures
• Verify the product complies with applicable standards
• Lead quality improvements for product and processes
• Support Internal and External Audits

Manages the Quality and Compliance departments (Quality Systems, Supplier Quality, Software Quality Assurance, Q&C New product Development)
• Oversees directly and indirectly organization of Quality and Compliance professionals, such as engineers and scientists that focus on quality aspects of development, lifecycle, supply chain, production and support. Includes partnership in new product development and leadership in supplier qualification, product release, field actions and complaint resolution activities.
• Leads effective establishment of organizations that support business process and compliance, quality risk management, design assurance, internal audits, corrective and preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines
• Partners with business and functional leaders to drive risk mitigation, proactive action, and continuous improvement.

• Interfaces with the designated Official Correspondent, Notified Bodies and Regulatory Authorities in matters of communications, actions and inspections and audits.
• Acts as Management Representative and the Person Responsible for Regulatory Compliance (PRRC)for HTC site.

A Fact: 10% of the older population will suffer from heart rhythm disorder.
You can become an expert in the mission of improving their lives!
Design and implement SW components and algorithms for Medical Device products, written in C++ and C# on a multi-threaded system.
This is an exciting opportunity to work with highly talented engineers, working on one of the most cutting-edge technologies.

A Fact: 10% of the older population will suffer from heart rhythm disorder.
You can become an expert in the mission of improving their lives!
Design and implement 3D SW components and computer graphics algorithms for Medical Device products, written in C++ and C# on a multi-threaded system.
This is an exciting opportunity to work with highly talented engineers, working on one of the most cutting-edge technologies.

We are looking for a Cloud Architect to join our Digital Platform team that develop cloud solutions that are connected to our medical systems.
The cloud-based system provides the physicians with AI based Big Data analytics tools to improve the EP procedures.
In this role you must demonstrate high professional skills, fast technology adoption, and ability to work on an Azure cloud environment.

Responsibilities:
• Design state of the art cloud solution on the Azure cloud including:
• Managing cloud solution with 100's servers
• Managing Big Data
• Operating and optimizing AI based analysis
• 3D presentation solutions based on GPUs, rendering technology
• Adopting latest Cybersecurity and Privacy technology
• Solution for the clinical needs as presented by our customers (Leading Physicians) and algorithm team
• Explore new technologies and tools to maintain cutting edge solutions
• Guiding the developers with the leading technologies
• Working with partners to define integrated solutions
• Developing the most complex component in the solution
• Being the technology expert is Agile development with emphasis on optimal architect, scalability, performance, Cybersecurity, code quality, and answering regulations.
• Work with Cybersecurity & Privacy team, Regulation and Quality functions to ensure alignment with medical device and data standards.