דרושים Systems Design & Project Lead - Technical Fellow ב-Boston Scientific ב-United States, Santa Clarita

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.

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:

As the Manager of Instructional Design, you are responsible to develop, design, and administer training content, programs, and meetings for our Neuromodulation field selling organization. You will be responsible for establishing and executing sales training measurements of success, ROI, and methods for program improvements. Additionally, you will manage the maintenance of all training materials and develop the capabilities of individuals on the Learning & Design team.

Key Responsibilities:

• Design Training Curricula: Create comprehensive sales training curricula, including content outlines, learning objectives, and instructional strategies to address identified needs and objectives.
• Develop Training Materials: Produce engaging and interactive training materials, including presentations, e-learning modules, job aids, and assessments using various instructional design tools and technologies.
• Create Multimedia Elements: Develop storyboards and scripts for multimedia elements, such as videos, simulations, and role-plays, ensuring alignment with learning objectives and instructional design principles.
• Assessment and Improvement: Implement assessment strategies to measure the effectiveness of training programs and analyze performance data to identify areas for improvement.
• Collaborate with Stakeholders: Partner with subject matter experts, sales leaders, and other stakeholders to gather input, validate content, and ensure training materials meet the needs of the sales team and the organization.
• Strategic Projects: Work with the Directors & Managers of Sales Training, VP of Sales, and VP of Commercial Excellence on various strategic projects to develop the Neuromodulation sales team.
• Marketing Collaboration: Collaborate with the Marketing team to influence and execute training strategy.
• Budget Management: Work with the Finance team to manage the global training budget.

Minimum Qualifications:

• BA/BS in a business discipline or equivalent experience
• Minimum of 3 years of experience in learning, sales, and/or marketing or previous experience with training development and design.
• Minimum of 3 years of experience in the medical device or healthcare industry.
• Strong oral and written communication skills.

• Ability to interact effectively with all levels within the organization and with external vendors/consultants.

• Strong project management experience and strategic thinking skills.

• Preferred background in people management.

• Ability to determine and set direction.

• Strong relationship-building skills with customers and team members.

• Energetic, enthusiastic, determined, and goal-oriented.

• Ability to grasp technical content.

• Results-oriented team player.

• Excels in a fast-paced, competitive environment.

• Creativity and the ability to think outside conventional wisdom to achieve mutually beneficial outcomes.

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

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

Solution Promotion and Sales:

• In collaboration with Divisional teams:

• Develop and implement go-to-market strategies for Capital Equipment remote connectivity solutions, with a strong emphasis on field-based customer engagement and solution selling.
• Define value proposition and pricing strategy for Software as a Service (SaaS) and Data as a Service (DaaS) offering. Align with Service Contract strategy.
• Engage directly with divisions and customers in the field to seek feedback and input on the value of the solution, promote and demonstrate the value, and drive usage and adoption.
• Identify and target potential customer segments, offering tailored solutions that meet their unique needs and enhance operational efficiencies.

Product Marketing and Brand Alignment:

• Craft a cohesive brand narrative for remote connectivity, ensuring that messaging aligns with company objectives and resonates with customers across diverse healthcare settings.
• Collaborate with product, regulatory, and divisional marketing and sales teams to deliver clear, compliant messaging that addresses customer pain points and highlights the solution’s benefits.

Customer Engagement and Training:

• Work with Divisions to support:

• Customer onboarding and training related to remote connectivity solutions.
• Development of customer-facing resources, presentations, and training materials to enhance understanding and promote adoption.
• Collection and analysis of customer feedback to continually improve the product and customer experience.

Cross-Functional Collaboration:

• Work closely with IT, Biomed, legal, and other relevant departments to address cybersecurity and legal challenges associated with remote connectivity.
• Coordinate with customer-facing and technical support teams to ensure seamless integration and adoption of connectivity solutions within healthcare environments.

Regulatory and Compliance:

• Partner with divisional Regulatory and Compliance teams to ensure that all marketing and sales efforts meet industry standards, particularly for Class II and Class III medical devices.
• Partner with divisional Regulatory and Compliance teams to address cybersecurity and legal considerations in solution messaging, reassuring customers of data safety and regulatory compliance

Required qualifications:

• 7+ years of experience in product marketing, solution selling, or customer success management within the digital health, medical device, or healthcare IoT industry.
• Proven cross-functional collaboration skills, with demonstrated experience addressing legal, cybersecurity, and compliance requirements for connected medical solutions.
• Sales and field engagement experience with a focus on driving solution adoption through direct customer interaction and fieldwork.
• Technical and regulatory knowledge related to Class II and Class III medical devices, including familiarity with cybersecurity protocols and compliance standards.
• Excellent communication skills, both written and verbal, with the ability to present complex technical information clearly and persuasively to various audiences, from clinical staff to IT professionals.
• Bachelor’s degree in marketing, Business, Biomedical Engineering, or a related field (advanced degree preferred)

Preferred qualifications:

• Master’s degree in marketing, Business Administration, Biomedical Engineering, or a related field.
• Experience in digital health or IoT product management, especially with healthcare connectivity solutions.
• Project management skills, with the ability to manage multiple projects simultaneously and deliver results in a dynamic environment.
• Customer-centric mindset with a strong orientation toward customer satisfaction and successful product adoption.

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 Design Quality Assurance Fellow will develop, establish and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional quality goals and priorities. Serves as a liaison for development teams to support compliance related project goals. Collaborates with Quality management to recommend, design and implement functional process improvements and guidance on compliance related matters. May mentor less experienced Quality staff, as well as other cross-functional stakeholders on implementing Quality processes and procedures as appropriate.Your responsibilities will include:

• Supports Quality System PIR and Field Action sub-process through managing and supporting the PIR/FA process
• Maintains collaborative relationship with Regulatory Agencies, specifically FDA.
• May author, executes, and will supports all aspects of Field Action documentation working closely with Post Market Communication team, regulatory and Field Actions teams.
• Identifies, develops, establishes, maintains, and improves quality systems methodologies, systems, and practices which meet company and regulatory requirements.
• Serves as an expert-level Quality representative to improve awareness, visibility, and communication on quality system initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
• Provides focused quality systems compliance expertise within product development, operational, or system/services support.
• Advanced-level aptitude in interpreting and applying external quality system management regulations and standards.
• Provides project direction, coaching, and mentoring for quality system personnel at all levels of the organization.
• Bridge the gap on the Global vs local Quality System documentation by proactive review and assessment.
• Drives improvement within the organization as well as global level improvement and changes to support QMS, CAPA, PIR etc
• Supports the development team on strategy and compliance around, new product development, sustaining and HFA (Human Feasibility Assessment studies.
• Supports the organization by combing the business needs with compliance and setting the right strategy for success.
• Assesses local and global processes and establishes the most efficient path to drive the organization forward.
• Works as a liaison between Med Safety and PIR team, by working with the CIS team to drive data as needed to support complex CAPAs or PIR activities
• Works with CAPA team to support and drive risk evaluations and updates
• Is responsible for CAPA sign off for all CAPA resulting from PIRs

Required qualifications:

• Bachelor’s of science degree
• Minimum of 10 years relevant experience, preferably in medical device industry
• Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management:  21 CFR Part 820, ISO 13485, AIMDD, MDD, MHLW, MDR SOR/98-282, 21 CFR Part 211, ISO 14971

Preferred qualifications:

• Master’s degree and 7+ years relevant experience, preferably in medical device industry or other regulated industry
• Experience working on PIRs or evaluations supporting field action decisions
• Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
• Excellent verbal / written communication, interpersonal, project management, and organizational skills; must be able to multi-task, and analyze information quickly
• Ability to communicate with all levels of the organization
• Must be able to work independently, lead and / or participate as part of a team
• Must be proactive, work independently, and be a contributing member of a highly visible team
• Must have working knowledge of Medical device product development cycle
• Must have experience working on NCEPs, CAPAs and Field Actions
• Prior experience working on Class III medical device projects
• Prior experience working on HFA (Human Feasibility Assessment) projects
• Prior experience leading teams on complex CAPAs
• Prior experience interfacing with auditors or investigators directly, supporting Quality System audits
• Design Quality experience

Maximum Salary: $ 243000

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 Associate Design Assurance Director will ensure that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. The Design Assurance (DA) Associate Director will work with the existing DA teams to: Ensure product safety, reliability and quality through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and manufacturing stages of the product. Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Exceed customer expectations by responding to field events in a professional and timely manner. Minimize the number of field events by building in quality into the design, through effective analysis of returned products, corrective actions and timely investigation and response to field events and post market monitoring through post market surveillance activities.

Your responsibilities will include:

• Recruits, coaches and develops organizational talent.
• Manages both NPD, Sustaining and VIP activities with existing DA teams.
• Represent QA in internal and external audits as a facilitator and SME.
• Works closely with PMO to ensure the division is properly resourced to support projects
• Drives PIRs, may own or contribute to the PIR process/document.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creates an entrepreneurial environment.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, TUV, EUMDR regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.

Required qualifications:

• Bachelor’s degree (Engineering)
• Minimum of 5 years of Design Assurance
• Minimum of 5 years of leadership experience

Preferred qualifications:

• Master’s degree (Engineering)
• Minimum of 5 years of supporting product development
• Minimum of 10 years’ experience in medical devices
• Solid understanding of US and OUS regulations and requirements for product development
• Prior experience in Process Development, PMO, Reliability, Complaints handling
• Experience with complex capital equipment
• Experience with product that include Software or embedded firmware
• Experience with active implantable devices

Maximum Salary: $ 266000

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.