דרושים Principal Systems Engineer ב-Boston Scientific ב-United States, Santa Clarita

As the Office Services Supervisor, you will oversee day-to-day office operations to ensure an efficient, productive, and engaging workplace environment. Partnering with local and regional leadership, you will support facilities management, real estate activities, and vendor coordination, while helping drive Boston Scientific’s workplace strategy. Reporting to the Office Services Manager, EMEA, this role plays a key part in maintaining a high-quality employee experience across our Warsaw office.

Your responsibilities will include:

• Managing real estate activities such as site leases, contracts, negotiations, renewals, and terminations in coordination with Global Real Estate and Legal.
• Driving workplace strategy by monitoring space utilization, capacity planning, and population forecasting to support strategic site planning.
• Leading day-to-day office operations, including vendor and contract management, janitorial services, canteen/café services, office supplies, and reception.
• Supporting capital projects, including budgeting, reporting, and ensuring compliance with global design guidelines.
• Guiding, coaching, and developing employees where applicable, while fostering a diverse and inclusive workplace culture.

Required qualifications:

• Bachelor’s degree in a relevant field and minimum of 5 years' experience in a professional role.
• Proven experience in office or facility management and people management within international organization
• Demonstrated success in project and budget management.
• Strong organizational and problem-solving skills with the ability to work independently.
• Excellent communication skills in English and fluent Polish
• Proficiency in MS Office applications

What we can offer to you:

• Exposure to a collaborative and multicultural environment.
• Career development in a fast-growing and innovative organization.
• Language courses and continuous learning support.
• Free and confidential counselling services (psychological, legal, financial).
• Comprehensive benefits package including parental leave, private medical care and life insurance.
• Access to company stock purchase program, lunch and sport cards.

Your responsibilities will Include:

• Support detailed project planning in support of major project, product/process transfer etc.
• Co-coordinating the activities of any BSC allocated project resources.
• Support the PM to identify and manage project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies.
• Development of and adherence to project contract or terms and conditions.
• Liaise with project manager, other team members, and functional management as necessary and effectively communicates project expectations and deliverables to team members in a timely and clear fashion.
• Development and implementation of appropriate supporting documentation and project management tools (meeting notes, decision log, risk matrix, Terms and Conditions)
• Prepare project status updates
• Support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.
• Identify and escalate unresolved obstacles to the success of the project.
• Participates in the planning, execution, and finalization of projects according to strict deadlines, within budget, and by following organized and repeatable procedures.
• Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements.
• Use critical thinking to offer new ideas and potential improvements to the project plan

Required qualifications:

• 3+ years related experience to include leading or managing projects
• 2 yrs experience in data management and technology systems implementation
• Strong data analysis skills
• Strong familiarity with Microsoft Tools and ability to learn software quickly
• Concise verbal and writing communication

Preferred qualifications:

• 3+ years medical device industry experience
• Preferred experience in process development and leading continuous improvement
• Experience in creating & facilitating communication to stakeholders
• Bachelor’s degree

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.

About the role:
– Mobile Applications will serve as a technical leader and hands-on developer responsible for designing, developing, and maintaining advanced Android and cross-platform mobile applications development.

Your responsibilities will include:

• Lead the architecture, design, and development of mobile applications for implantable medical devices using Kotlin Multiplatform and Core Java.
• Ensure secure communication between devices and cloud systems via Bluetooth Low Energy (BLE) and AWS-based APIs.
• Develop and maintain libraries and SDKs for cross-platform mobile applications.
• Integrate mobile applications with AWS cloud infrastructure (KMS, S3, DynamoDB, Cognito, API Gateway, EC2, CloudWatch).
• Author and review key design documentation: architecture specs, DFMEA, cybersecurity reports, threat models, etc.
• Conduct peer reviews and maintain code integrity, ensuring traceability and compliance per med device process.
• Lead Agile/Scrum ceremonies, mentoring distributed teams (U.S., Costa Rica, India, China, Ukraine) across time zones.
• Estimate timelines, propose plans, review milestones and lead app development from concept through commercialization.

Required qualifications:

• Bachelor’s or Master’s degree in Computer science, Software Engineering, or related field.
• 10+ years of experience in Android mobile app development, with at least 3+ years in medical device application.
• Experience of architecting, designing and developing of mobile applications.
• Strong command of Kotlin, Kotlin Multiplatform, Java and Android Jetpack architectures (MVVM, Rx, XML data binding).
• 3 + years’ experience with AWS services and secure communication protocols (BLE, Wi-Fi, HTTPS, OAuth).
• Experience with CI/CD (Jenkins, Git), SonarQube, and Atlassian Agile tools.
• Good understanding of IEC 62304, ISO 13485, and FDA design controls for medical device software.
• Demonstrated leadership in cross-functional R&D environments and distributed global teams.
• Excellent communication skills with the ability to collaborate across global teams AND documentation for regulatory deliverables.

Preferred qualifications:

• Experience in Developing Mobile apps for Neuromodulation devices.
• Prior experience with medical device connectivity.
• Prior experience on secure BLE communication, data encryption, and integration with AWS cloud services (S3, DynamoDB, Cognito, API Gateway)
• Experience in cybersecurity techniques (sandboxing, code obfuscation, penetration testing).
• Exposure to data science or machine learning frameworks (TensorFlow, Pandas, NumPy, R).

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.

Job Description:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management

• Interacts cross functionally and with internal and external customers

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit

• SME for Calibration Management System

• Manage and Perform calibration functions. Sets day to day function for calibration group

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Manage calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Senior Metrology Engineer and Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements

Job Requirements:

• Candidate required possess at least Bachelor's Degree in Engineering.

• Required at least 5 ~ 8 years of working experience in related field.

• Prefer candidate with possesses hands-on experience in manufacturing and process engineering, with a proven track record in problem-solving and process improvement. Additional advantage includes experience in people management.

• Skill required: Strong analytics skill, problem Solving and Process Improvement knowledge and leadership skill.

Key Responsibilities:

• Serve as the primary owner and administrator of the division’s Learning Management System (LMS) and related learning technologies.
• Partner with subject matter experts to design engaging, learner-centered training content using instructional design models (ADDIE, SAM).
• Develops eLearning content using industry standard tools (e.g. Articulate Storyline, Articulate Rise) focused on learner engagement and measurable impact.
• Creates job aids, reference guides, videos and simulations to support on-the-job application and reinforcement of learning.
• Maintains brand, style and compliance standards across all learning assets.
• Manages learning projects to ensure they meet the project, budget and timeline requirements.
• Manage system configuration, user management, reporting and data integrity to ensure accurate training records.
• Collaborate with IT, HR and enterprise learning teams to maintain system security, compliance and integration with other platforms.
• Evaluate and recommend new learning technologies that enhance learning delivery, interactivity and performance measurement.
• Assesses training needs by evaluating sales force knowledge, skills and abilities (KSAs) related to new business development tools. Identifies gaps and recommends solutions to ensure effective and efficient utilization of learning technologies.
• Conducts ride along visits with field personnel to better understand best practices and ensure adoption of business development tools.
• Supports and monitors projects with division-wide impact and ensures systems align with long-term business objectives.
• Participates in the selection of software to meet business requirements.
• Builds strong partnerships with sales training, marketing and commercial excellence teams to align learning programs with strategic priorities.
• Attends professional conferences to build networks of contacts, advance technical knowledge, and ensure professional expertise is maintained.

Required Qualifications:

• Bachelor's Degree in Education, Instructional Design, Education Technology or related field. Master’s degree preferred.
• 5+ years’ experience in instructional design and learning system administration, preferably in the medical device or healthcare environment.
• Proficiency with LMS administration and eLearning authoring tools (e.g. Articulate, Storyline, Articulate Rise, Camtasia, Adobe Captivate).
• Demonstrated expertise in instructional design and eLearning development supported by a portfolio of work samples showcasing design, process and multimedia assets with final deliverables (e.g. eLearning modules, simulations, job aids, videos).
• Strong understanding of adult learning theory, instructional design models and eLearning best practices.
• Proven ability to manage multiple projects in a fast-paced environment.
• Excellent communication and collaboration skills.

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.

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.

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.