Systems Engineer II
Company: Boston Scientific
Posted on: June 20, 2022
About the roleWe are looking for a Systems Engineer to become a
member of a dynamic team that provides technical leadership with a
mix of mechanical, electrical, software, and catheter engineers and
an interdisciplinary team of Marketing, Regulatory, and Quality.
This individual will work on new projects from concept to
commercialization and projects that maintain our currently released
mapping system. The individual will be responsible for defining,
analyzing and implementing system requirements, risk analysis, and
usability as well as provide input to cross-functional
deliverables. Key Responsibilities
- Defines and analyzes system requirements, clinical workflows,
and input/output processes by using current systems engineering
methods and technologies.
- Solve system problems by analyzing the situation and
recommending corrective or alternative actions.
- Documents system architecture and design control elements by
writing documents, reports, and memos.
- Collaborates in the translation of customer needs into
technical requirements, engaging the field, marketing, service and
other functions as needed.
- Provides expertise and conducts evaluation of validation and
- Assist with industry-based standards testing for safety and EMC
according to 60601-1
- Supports the risk analysis for the project.
- Works with a cross-functional team and serves as an R&D
representative on cross-functional deliverables.Basic
- Engineering degree (EE, computer science, or biomedical) and
experience driving projects and tasks to closure.
- 3-5 Years of experience within the Medical Device industry with
BS degree, 0-3 Years with MS or PhDPreferred Qualifications
- Medical Device experience working with imaging and signal
processing systems (EEG, Electrophysiology, etc.).
- Experience conducting simulations, mathematical analysis and/or
system interaction analysis.
- At least 2 years of engineering experience in mixed HW/SW
- Technical experience with digital and analog low noise
- Usability engineering experience.
- Experience with IEC 62304
- Strong communications and time management abilities.
- Ability to provide technical leadership within cross-functional
- Track record of independent and solution-oriented work style.
Quality System Requirements
- In all actions, demonstrates a primary commitment to patient
safety and product quality by maintaining compliance to the Quality
Policy and all other documented quality processes and
- Assures that appropriate resources (personnel, tools, etc.) are
maintained in order to assure Quality System compliance and
adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the
Quality Policy and Quality System.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 care 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 drug-free workplace.
Under Va. Code - 2.2-4312 (2000), 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.
Keywords: Boston Scientific, Cambridge , Systems Engineer II, Other , Cambridge, Massachusetts
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