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- Experience leading and growing a system engineering team including recruiting, hiring, mentoring, professional development, and performance coaching.
- Develop the system engineering discipline cross functionally through focus on system architecture and a system of systems mindset.
- Oversight of Systems Requirements development and requirements management tool development
- Creation of organization competency in translating clinical needs to NPD teams.
- Leadership of planning and execution of systems level testing, including test manual any automated systems test development.
- Responsible for organizational fluency in key standards for capital equipment and SUD such as ISO 60601.
- Participates in cross functional franchise level leadership (planning and execution)
- Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Creates an entrepreneurial environment.
- Provides general direction to managers, exempt specialists and non-exempt support in various areas, groups and/or operations.
- Keeps the organization's vision and values at the forefront of decision making and action.
- Demonstrates effective change leadership.
- Builds strategic internal and external partnerships to further departmental and organizational objectives.
- Cultivate a culture of continuous improvement by staying informed about industry trends, technological advancements, and emerging tools in medical device systems engineering, human factors, design controls, reliability testing, and software development.
- Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
- Directs and controls the activities and budget of one or more functional areas, divisions, product groups and/or operations.
- Makes and executes operational decisions with a strategic perspective.
- Travel expectations 25-30%
- Successful history of launching and maintaining products within the medical device industry
- Demonstrated expertise in design, development and testing of software based medical devices.
- Working knowledge of hardware, firmware and software evaluation to standards IEC 62304, , 21CFR Part 11 and ICH E6 Good Clinical Practice.
- Experience working with requirement management, collaboration and issue tracking tools such as Jama, and Jira at the customization level.
- Significant experience working with agile software development methods such as Scrum.
- Experience with cyber security and privacy policies and design requirements.
- Experience with performance and reliability test strategies and tools.
- Bachelor of Science degree in a relevant engineering discipline with 10+ years of experience developing highly complex systems
- 5+ years' experience managing technical teams in the development of medical device software.
- Leads a group or team of employees in the development and achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
- Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
- Will direct and control the activities, budget, and headcount for the systems engineering organization.
- Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).
- Be able to lead a cross functional site and build engagement.
R&D Systems Director - Cambridge, United States - Boston Scientific
Description
Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.
Purpose Statement:
The Systems Director will provide leadership, vision, and direction for the EP R&D Systems Engineering organization. Responsible for strategic team leadership, driving system of system methodology, synthesis of system architecture & systems requirements/ verification.
Responsibilities:
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.