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System Engineer/System Analyst IRC122395

Job: IRC122395
Standort: US - San Jose, Remote
Bezeichnung: Consultant
Erfahrung: 5-10 years
Funktion: Engineering
Fähigkeiten: Requirements elicitation (gathering)
Remote Yes

Beschreibung:

We are looking for an experienced System Engineer to participate in the development of software as a medical device (SaMD) project. This role will work with cross-functional teams  to Responsibilities of System Engineer include:

Anforderungen:

     

    • Bachelor or more advanced degrees in Biomedical Engineering, Systems Engineering, Electrical/Electronic Engineering, Computer Science, or other relevant disciplines

    • Minimal 5 years of experience in medical device development, or other highly regulated industries from concept phase to commercial launch

    • Strong communication skills for both technical discussions with dev team and also for alignments with business stakeholders

    • Experience working with the requirements management tools and traceability management tools, previous experience of CodeBeamer a plus.

    • Well-versed in medical device or SaMD development, Quality Management System, and regulatory processes (ISO 13485; IEC 60601, 62304)

    • Knowledge of the best practices for software development: Methodology (Agile and V-Model) and tooling (CI/CD, Automation, Requirement Management, etc.).

    • Experience defining cybersecurity requirements, data privacy and system performance requirements.

Einstellungen:

N/A

Arbeitsaufgaben:

    • Design and implement systems engineering approach to support the development and life cycle management in the areas of SaMD.

    • Demonstrate strong technical know-how at the system level and guide the project teams for product development on defining pain points, user needs and technical design input requirements.

    • Structure and visualize the system using systems modeling tools and integrate into a wider ecosystem.

    • Utilize the system engineering tool for requirements management and translate user and business needs into system/sub-system requirements.

    • Actively maintain and monitor the traceability from the requirements to the verification activities

    • Implement risk management at the systems level and coordinate risk management activities at the component level.

    • Facilitate design input with cross-divisional teams, programs, and stakeholders.

    • Author relevant design history files and GMP compliant documentation.

     

Was wir anbieten

Exciting Projects:Come take your place at the forefront of digital transformation! With clients across all industries and sectors, we offer an opportunity to work on market-defining products using the latest technologies.

Collaborative Environment: You can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities!

Work-Life Balance:GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules and opportunities to work from home.

Professional Development:We provide continuing education classes, professional certification and training (technical, soft skills, language, and communication skills) to help you realize your professional goals. Being part of a global organization, there are additional learning opportunities through international knowledge exchanges.

Excellent Benefits:We provide our employees with competitive salaries, health and life insurance, short-term and long-term disability insurance, a matched contribution 401K plan, flexible spending accounts, and PTO and holidays

Über GlobalLogic

GlobalLogic is a full-lifecycle product development services leader that combines chip-to-cloud software engineering expertise and vertical industry experience to help our customers design, build, and deliver their next-generation products and digital experiences. We expertly integrate design, complex engineering, and agile delivery capabilities to deliver superior business outcomes for global brands in telecom, automotive, healthcare, technology, media and entertainment, manufacturing, and semiconductor industries.

Headquartered in Silicon Valley, GlobalLogic employs over 18,000 designers and engineers across the globe. Analysts like NASSCOM and Zinnov have recognized us for being a top company in our field, and we are consistently nominated as a preferred employer by both global HR consultative firms and local job boards. By creating a work environment that is exciting and flexible, and by fostering growth through ongoing learning and development programs, we empower our employees to achieve both their professional and personal goals.

At GlobalLogic, we make amazing products — and careers.

Apply Now

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    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
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    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com
    Recruitment for this and similar positions in GlobalLogic, a Hitachi Group Company is constantly open. In order to apply and give GlobalLogic your consent to process your personal data for the purpose of such recruitments press the “Apply” button below. More details on how we process your personal data and what are your rights can be found in EU & UK Recruitment Privacy Notice. Remember that you can withdraw your consent anytime, for example by sending an e-mail at privacy@globallogic.com
    In order to apply and give GlobalLogic, a Hitachi Group Company your consent to process your personal data for the purpose of this recruitment process, press the “Apply” button below.
    Check this box if you want us to process your personal data also for future recruitment processes for other positions. More details on how we process your personal data and what are your rights can be found EU & UK Recruitment Privacy Notice. Remember that you can withdraw any consent anytime, for example by sending an e-mail at privacy@globallogic.com