דרושים Embedded Software Verification Engineer Iii ב-Boston Scientific ב-United States, Santa Clarita

The Principal Field Clinical Engineer (FCE) supports a growing department that manages a large pivotal study program based on an innovative medical device technology platform. The Senior FCE will be responsible for all aspects of case support and product education aimed at treating product education involving coronary interventions, including calcium modification. This role will be reporting to Director, Field Clinical Operations.

⦁ Minimum Bachelor’s degree in Engineering, Anatomy, Physiology related field or equivalent healthcare experience required.
⦁ Minimum 5 years of experience in clinical research experience including coordinating multi-center trials with established technical expertise and knowledge
⦁ Ability to travel upto 75-90% domestically and internationally. Visits include clinical sites and centers.
⦁ Experience in presenting, writing and teaching clinical and medical information
⦁ Experience with group presentations and hands-on experience with surgical catheter based interventions
⦁ Must be able to work effectively with internal groups such as R&D, Quality, Regulatory, technical specialists, and external stakeholders achieve assigned goals
⦁ Ensure compliance with clinical study protocol, and identifying areas of concern and escalating when appropriate

⦁ Excellent written and verbal communication skills, very strong interpersonal skills including proficiency in medical terminology
⦁ Clinical Research experience in Medical Device
⦁ Experience coordinating multi-center Cardiology trials
⦁ Knowledge of Good Clinical Practices and trials, including feasibility IDE and post- market studies.

Maximum Salary: $ 197000

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.

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Your Responsibilities Includes:

• Product Demand Planning: Lead forecast development at the product family/SKU levels via collaboration with cross-functional partners; manage forecast system inputs and improve forecast accuracy/reduce forecast bias.
• Facilitate monthly SI&OP process/meetings and create PowerPoint presentation decks for demand planning and net requirements; independently collaborate with global planning teams to understand drivers of build requirement changes and clearly communicate them to manufacturing or SFMD partners.
• Identify and monitor performance to forecast by utilizing GSC key performance indicators and reporting tools.
• Work closely with manufacturing partners in ensuring product build plans & delivery schedules are appropriately aligned to global inventory needs. Identify gaps between financial, production and consensus demand plans and collaborate with appropriate cross functional teams to mitigate the gaps.
• Assist with and in some cases own team projects & other initiatives such as new product launches, end-of-life planning, distribution network changes and country expansions.
• Contribute to the development of inventory plans. Monitor inventory performance to plan and target. Assist GSCM with the management of expired, excess, and obsolescence reserves.
• Collaborates with Regional or Country Planners in ensuring their demand plans are accurate and inventory is appropriately managed/balanced across multiple DC sites.

Required Qualifications:

• Bachelor’s degree in Supply chain, Business, Industrial Engineering, or related field
• 3+ years of work experience in Supply Chain, Supply planning, Production, Inventory management or related functions
• Working experience with systems such as MRP, SAP, ERP
• Strong PC skills in Excel, Word, and PowerPoint
• Consistently performs to a high level of accuracy and with a high attention to detail.
• Adaptable, flexible, and willing to accept new ideas, processes, and procedures.
• Strong analytical skills: able to efficiently use data to make good decisions.
• Strong communication skills: able to present information to varying levels of an organization.

Preferred Qualifications:

• Preferred experience in the medical device or biotech industry
• Preferred experience using SAP, Rapid Response/Kinaxis, or other ERP systems.
• Extensive experience collaborating with cross-functional teams (e.g., Marketing, Sales, Finance, Distribution Centers, International offices, Suppliers, Manufacturing)

Maximum Salary: $ 121400

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 This Role

As a Senior Systems Engineer for the Boston Scientific Neuromodulation R&D team, you will play an important role in systems design from concept to product launch across implantable and connected cloud & mobile product systems. As a Senior Systems Design Engineer, you are responsible for system level design of complex implantable medical devices by developing system requirements from user needs and stakeholder inputs, designing and documenting system architecture, and guiding the implementation of system features through hardware/firmware/software development and verification activities. You will provide support for system integration activities using systems engineering principles and techniques.

Key Responsibilities

• Provide technical leadership on a cross-functional engineering team
• Define and analyze system requirements, clinical workflows, and input/output processes by using systems engineering methods and techniques
• Apply critical thinking to solve systems integration problems and make recommendations
• Utilize architecture design tools to develop and document system-level interactions
• Create design documentation such as requirements rationale, requirements tracing, system change analysis within our quality system
• Writing reports for and working with internal regulatory team to satisfy the requirements for external regulatory agencies
• Apply project management principles to plan, track, execute, and report status of projects within a range of team sizes
• Support system risk management activities, such as FMEA’s and risk/hazard analysis

Required Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science or related field
• 6+ years of engineering experience. Master’s may substitute for 2 years of experience
• 4+ years of engineering experience in mixed HW/SW systems
• 2+ years of experience in the design, development, and testing of embedded systems and/or active implantable medical devices
• Ability to interpret and develop system requirements and system specifications
• Experience with general electronic bench test equipment: oscilloscopes, DMM's, Data Acquisition devices
• Effective communication skills (both written and verbal) to all levels of the organization
• Willingness to work onsite in hybrid mode (3+ days per week) at our Valencia, CA site

Preferred Qualifications

• Track record of independent and solution-oriented work style
• Experience in system development lifecycle process including formalized processes and procedures
• Ability to interpret and apply regulations and standards relevant to class II/III medical devices
• Familiarity with requirements management/PLM tools
• Experience in product concept development, customer interaction, verification of engineering requirements, and validation of customer needs/design requirements
• Strong written and verbal communication, judgment, decision-making, and critical thinking skills
• Ability to build relationships across the organization and with external stakeholders
• Ability to provide technical leadership within cross-functional teams
• Practical knowledge of project management concepts and exposure to Agile methodologies

Maximum Salary: $ 164500

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

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:

In this pivotal role, you will be expected to leverage your extensive experience to tackle complex technical challenges and drive innovation within the team. Your proactive approach and problem-solving skills will be crucial as you navigate the intricacies of software testing and development. By embracing new technologies and methodologies, you will ensure the robustness and reliability of our software solutions, thereby contributing to our mission of improving patient outcomes through cutting-edge neuromodulation technologies. Your collaboration with cross-functional teams will be instrumental in achieving our strategic goals and delivering high-quality products to the market.

Your Responsibilities will Include:

• Manage the test automation team, provide guidance and mentorship to SQEs and SDETs

• Lead and manage automation testing projects from inception to completion.

• Design, Develop and implement test automation strategies and plans and implement robust and scalable test automation frameworks.

• Creating automated tests in Python using Pytest for Surface Pro application and mobile application and API tests

• Identify opportunities to improve test automation processes and tools.

• Stay up to date with the latest trends and technologies in test automation.

• Being able to extract and create Test Plan by reviewing design documents, technical requirements, and Jira stories, and maintaining them during project lifecycle

• Familiar with test case management like JIRA and Zephyr to create test suites, and detailed test steps to ensure requirements traceability and test coverage

• Familiar with using general mobile devices to interact with devices via Bluetooth, NFC, Wi-Fi, and using mobile applications to interact with our devices

• Comfortable interacting and working directly with Development, Program Management, to get the necessary support regarding key deliverables and interacting with them to resolve issues quickly and efficiently

• Being able to reproduce issues reported, or as needed during regression and product verification during testing and after release to production

• Proficient oral and written communication skills

Required Qualifications:

• Bachelor's degree Electrical Engineering, Computer Engineering, Computer Science or a related field

• 4 years of experience with Python test framework development experience

• Hands-on experience with leading automation testing for a large-scale customer-facing product releases

• Practical experience working within an Agile/Scrum/Kanban-based environment

Preferred Qualifications:

• Knowledge of wireless testing technologies, including Wi-Fi, Bluetooth connectivity etc.

• Experience with testing complex applications on desktop, tablets, mobile and web services

• Knowledge of software development and test methodologies - preferably in relation to the complexities created by a regulated environment.

• Ability to define and maintain an API that is used by multiple teams and multiple projects over a long time

• A strong interest in continuous learning about and adaption of new technologies and methodologies

• Many of our solutions require out-of-the-box thinking so a high level of creativity and flexibility is desirable.

• Ability to develop and maintain good relationships with cross-functional teams.

Maximum Salary: $ 164500

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

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

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

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 Software Quality Assurance Engineer III will serve as a Quality representative in the Neuromodulation Software/Firmware product development. The Software Quality Assurance Engineer III will provide Quality Engineering input throughout the product life cycle process. The Software Quality Assurance Engineer III will be actively participating in design activities of new product development and sustaining activities for commercialized product. The Software Quality Assurance Engineer III will be involved in the development, testing and validation of Software/Firmware products.

In the Neuromodulation division, we continue to advance science in electronic implantable technologies that help patients manage debilitating chronic pain and neurological conditions such as movement disorders.

Your responsibilities will include:

• Actively working within a team of Product Software Quality Assurance Engineers.
• Actively contributing to all aspects of Software/Firmware Quality Assurance activities in a highly regulated Active Implantable Medical Device environment.
• Ensures the Quality of software systems, validate product software and firmware requirements, security requirements and compliances.
• Support design, development, and test of software related to all Boston Scientific Neuromodulation product lines during their entire development life cycle, from requirements gathering phase to the retirement phase.
• Support the creation and execution of Design Validation Plan, Protocols and Reports to perform System level testing of Neuromodulation products and report any issues discovered.
• Perform review of design, development, and testing of software and firmware used in Boston Scientific Neuromodulation product lines.
• Perform review and approval of documentation associated with user requirements, hazard analysis, security risk assessment, usability, functional and design specifications, design reviews, test protocols, requirements traceability, etc.
• Actively working to support Automated Test Equipment validation activities.
• Actively working to support Software related CAPA.
• Support Design Validation activities, which encompass reviews of User Needs Requirements, Design Requirements, Functional, Architectural, Module Design Details, Code and Design reviews, Unit tests, Integration tests, System level (black box), Structural (white box), Test Automation, Ad-Hoc/Exploratory test activities, Cybersecurity, Usability, and Risk Management, Design FMEAs, and Hazard Analysis.
  

Required qualifications:

• Bachelor's degree in Software/Electrical Engineering/Biomedical Engineering
• 4+ years of working experience in software engineering and/or testing
• 2+ years experience in Programming Languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, LabView
• Manual system level testing experience
• Understanding of Software Development Life Cycle Processes per IEC 62304

Preferred qualifications:

• Master's degree in Computer Science or Software/Electrical Engineering
• Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, and several competing tasks from various departments (R&D, Marketing, Manufacturing, Quality and Regulatory, Clinical, Project Management, etc.)
• Must be detail oriented and have a passion to “Build Quality In” the products
• Experience working in the medical device industry or other highly regulated environment
• Basic academic knowledge of principles of Neuromodulation
• Some experience with CAPA, Complaint Handling and External Audit
• Experience/Understanding of Risk Management as per ISO 14971
• Understand Premarket Cybersecurity Guidance, Post Market Cybersecurity Guidance and 81001-5-1
• Understand Bluetooth technology
• Understand Mobile applications development
• Understand aspects of HIPAA and GDPR compliance practices
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE)

Maximum Salary: $ 151400

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:

In this pivotal role, you will be expected to leverage your extensive experience to tackle complex technical challenges and drive innovation within the team. Your proactive approach and problem-solving skills will be crucial as you navigate the intricacies of software testing and development. By embracing new technologies and methodologies, you will ensure the robustness and reliability of our software solutions, thereby contributing to our mission of improving patient outcomes through cutting-edge neuromodulation technologies. Your collaboration with cross-functional teams will be instrumental in achieving our strategic goals and delivering high-quality products to the market.

Your Responsibilities will Include:

• Manage the test automation team, provide guidance and mentorship to SQEs and SDETs

• Lead and manage automation testing projects from inception to completion.

• Design, Develop and implement test automation strategies and plans and implement robust and scalable test automation frameworks.

• Creating automated tests in Python using Pytest for Surface Pro application and mobile application and API tests

• Identify opportunities to improve test automation processes and tools.

• Stay up to date with the latest trends and technologies in test automation.

• Being able to extract and create Test Plan by reviewing design documents, technical requirements, and Jira stories, and maintaining them during project lifecycle

• Familiar with test case management like JIRA and Zephyr to create test suites, and detailed test steps to ensure requirements traceability and test coverage

• Familiar with using general mobile devices to interact with devices via Bluetooth, NFC, Wi-Fi, and using mobile applications to interact with our devices

• Comfortable interacting and working directly with Development, Program Management, to get the necessary support regarding key deliverables and interacting with them to resolve issues quickly and efficiently

• Being able to reproduce issues reported, or as needed during regression and product verification during testing and after release to production

• Proficient oral and written communication skills

Required Qualifications:

• Bachelor's degree Electrical Engineering, Computer Engineering, Computer Science or a related field

• 4 years of experience with Python test framework development experience

• Hands-on experience with leading automation testing for a large-scale customer-facing product releases

• Practical experience working within an Agile/Scrum/Kanban-based environment

Preferred Qualifications:

• Knowledge of wireless testing technologies, including Wi-Fi, Bluetooth connectivity etc.

• Experience with testing complex applications on desktop, tablets, mobile and web services

• Knowledge of software development and test methodologies - preferably in relation to the complexities created by a regulated environment.

• Ability to define and maintain an API that is used by multiple teams and multiple projects over a long time

• A strong interest in continuous learning about and adaption of new technologies and methodologies

• Many of our solutions require out-of-the-box thinking so a high level of creativity and flexibility is desirable.

• Ability to develop and maintain good relationships with cross-functional teams.

Maximum Salary: $ 164500

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

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

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

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:

• Provide Quality Engineering support for sustaining activities and improvement projects for commercial products, with a focus on the project of process relocations within BSC sites.
• Support Non-Conformance Event Prevention (NCEP) and Correction and Preventive Actions (CAPA) activities that include, but not limited to, containment tasks, risk analysis, problem-solving, cause investigations, and written documentation of activities.
• Investigate complaint data, reports, and trends that support projects, issues, and performance of products.
• Participated in project team meetings, contribute to the discussions with questions/feedback, and collaborated with team members to accomplish required project deliverables.
• Review and approve document deliverables in the document approval system. Provide feedback and proposed updates as needed to ensure clear, compliant information.
• Understand, support, and/or drive change assessment strategies.
• Monitor and track the progress of quality-related tasks and initiatives. Collaborate and follow up with team members to ensure completion of assigned tasks within established timelines.
• Communicate across functions and levels to ensure stakeholders are informed and aware of project status, issues, roadblocks, etc.

What we’re looking for in you:

Required Qualifications

• BS/BA Degree in engineering, or a related field.
• 2+ years of experience in quality engineering or related engineering discipline
• Proficiency in basic Microsoft Office applications (Word, Excel, PowerPoint, Project, Visio)
• Ability to travel up to 10% as needed

Preferred Qualifications

• 2+ years of experience in the medical device industry with an understanding of Quality System Requirements
• Strong technical writing skills and ability to clearly communicate complex information
• Ability to effectively and efficiently collaborate within cross-functional teams
• Problem solving experience with nonconformances and/or corrective actions
• Project/task management experience
  

Maximum Salary: $ 138300

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.