Jobs
>
Bengaluru

    Software Validation Quality Engineering Lead - bangalore, India - Intuitive

    Intuitive
    Intuitive bangalore, India

    6 days ago

    Default job background
    Description

    Company Description

    At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
    As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
    Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
    Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
    Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

    Job Description

    As Intuitive's da Vinci Surgical System continues to be adopted by an increasing population of hospitals, surgeons and patients, we are expanding our product offering to support a more comprehensive robotic program for our customers. As a part of this expansion this individual will support projects that fall within a new and growing team- Digital and data products.

    As a part of this expansion, we are looking for an ideal candidate to possesses a broad base of experience and a high level of technical depth in individual who will be assigned to work on digital and data software non-medical products . As part of the role, you will work in a highly skilled, multi-disciplinary team who you will coach, mentor, teach and influence in best software Quality practices.

    This is not a Software testing role.

    Roles and Responsibilities:

  • Responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements
  • Provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems
  • Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, ISO 13485, ISO 62304, 21 CFR Part 11, Annex 11 and Data Integrity
  • Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures
  • Support systems and new product introduction by serving as a Quality resource, providing expertise, problem solving, and strategies for problem prevention
  • Participate as the Product Quality representative in project team activities and process design to ensure cGxP compliance and interdepartmental consistency within the validation program
  • Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation
  • Coordinate and provide training and/or opportunities for career development of others
  • Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences
  • Serve as local focal point: act as mentor for the local team in India, assist with prioritization and assignments of tasks and report on progress to the global team

    • Qualifications

  • Education: Degree in software Biomedical engineering or equivalent technical discipline
  • 8+ years' hands on experience in SoftwareDesign/ Quality Engineering in a medical device/ Pharma industry with a focus on GxP system
  • Experience in a lead role/ managing a team is preferred
  • Hands-on experience with agile scrum process and tools (Agile/JIRA/Atlassian/Polarion).
  • Hands-on experience with Software Validation following 21 CFR Part 11, ISO 62304, and applicable medical device QMS & software Life Cycle process.
  • Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, 21 CFR Part 11, GAMP5, electronic record and electronic signature.
  • Experience working on low and high-risk software applications using a scalable approach to the SDLC practices and the QMS.
  • Ability to work in a geographically diverse business environment.
  • Attention to details and Quality are critical to success.
  • Excellent organizational, interpersonal, and verbal and written communication skills, with the ability to deliver quality outputs under minimum supervision.

    • Additional Information

    Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

    We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

  • Giant Eagle GCC

    Engineer, Lead

    6 days ago

    Giant Eagle GCC Karnataka, India

    Job Summary · Lead Engineer will take charge of our integration initiatives. Will play a pivotal role in architecting, designing, and implementing solutions that streamline financial processes and enhance overall system efficiency. Lead Engineer's expertise in will be critical ...

  • Larsen & Toubro

    Lead Engineer

    2 weeks ago

    Larsen & Toubro Bengaluru, India

    L&TTS is hiring Teamcenter Lead Engineer / Senior Developer for Bangalore / Hyderabad location. Kindly click on the link to apply for the position. · Interested to know more, feel free to reach out to us and share your updated resume to · Job Description: · Role: Teamcenter Lead ...

  • Quest Global

    Lead Engineer

    1 week ago

    Quest Global Bengaluru, India

    We are accepting Job Applications on Email as well · Direct Applications Accepted : · - · Email : bhuvaneswari.-;sunil.- · Offshore Wind Farm Foundations, Both Primary and Secondary Steel Design. · Senior Foundation Engineer · Offshore Foundation Design · Offshore Wind Farm / Off ...

  • Kenvue

    Lead Engineer

    6 days ago

    Kenvue Bengaluru, India

    As the Lead Engineer of Cloud Security, you will be responsible for leading the engineering, testing, and deployment of cloud security capabilities to secure our data, mitigate threats, and protect our digital assets. This role requires technical experience in multiple cloud envi ...

  • Target

    Lead Engineer

    5 days ago

    Target Bengaluru, India

    About us: · Working at Target means helping all families discover the joy of everyday life. We bring that vision to life through our values and culture. Learn more about Target here. · As a lead engineer, you serve as the technical anchor for the engineering team that supports a ...

  • Giant Eagle GCC

    Engineer, Lead

    6 days ago

    Giant Eagle GCC Karnataka, India

    Job Summary · Job Profile Summary · Lead Engineer will take charge of our integration initiatives. Will play a pivotal role in architecting, designing, and implementing solutions that streamline financial processes and enhance overall system efficiency. Lead Engineer's expertis ...

  • Kenvue

    Lead Engineer

    6 days ago

    Kenvue bangalore, India

    Lead Engineer · What You will Do ? · As Observability engineers you are passionate about using software-based approaches to solve complex data-driven challenges and automate those solutions. You will lead efforts aimed at setting up enterprise observability solutions at scale ...

  • GE Aviation

    Lead Engineer

    1 day ago

    GE Aviation Bengaluru, India

    Job Description Summary · The Lead Engineer is an individual contributor 'hardware owning' engineer reporting to an Engineering Manager within the Aerospace Engineering Division's Production Technologies team. As a hardware owner you will own all engineering functions related to ...

  • For All Health

    Lead Engineer

    3 weeks ago

    For All Health Bengaluru, India

    We are looking for a proactive and skilled individual to take on the role of Lead Engineer. You will be involved in building and developing the entire workflow of our flagship medical device's software and hardware. As our core engineer, you will set the development roadmap, eval ...

  • Kenvue

    Lead Engineer

    6 days ago

    Kenvue Bengaluru, India

    Kenvue GCC Bangalore · Lead Engineer · What You Will Do ? · As Observability engineers you are passionate about using software-based approaches to solve complex data-driven challenges and automate those solutions. You will lead efforts aimed at setting up enterprise observa ...

  • Seikor

    Lead Engineer

    6 days ago

    Seikor Bangalore, India

    Designation: Lead Engineer - Observability - Platform Engineering · Skill Set: Opentelemetry (No kubernets, working on distributed tracing and custom matrics), Java Scripts /type scripts knowledge, AWS RDS, ARORA, SQS, SNS, Kinesis, API Gateway, DynamoDB, AWS LAMBDA · Experience: ...

  • Neighborly®

    Lead Engineer

    1 week ago

    Neighborly® Bengaluru, India

    Company Overview · Neighborly is a holding company of 22 service brands, focused on repairing, maintaining and enhancing consumers' homes and businesses. The company operates online platforms that connect consumers to service providers in their local communities that meet their r ...

  • Creative Synergies Group

    Lead Engineer

    3 weeks ago

    Creative Synergies Group Bengaluru, India

    About Creative Synergies Group: · Global technology services company · 40+ Fortune 500 clients · 95% revenue from US, Europe, Japan based customers. · Current Verticals: Transportation, Energy/Process Industry, Industrial Products, Hi-Tech · Service offerings: · Product Engineeri ...

  • Kenvue

    Lead Engineer

    6 days ago

    Kenvue bangalore, India

    Job Description · Kenvue is recruiting for a Full Stack Software Engineer – Cloud Native, to be part of a forward-looking, innovative, and outcome-minded team of software professionals that build platforms and applications for our consumer 2ealth business, enabling the future of ...

  • GE Aviation

    Lead Engineer

    3 weeks ago

    GE Aviation Bengaluru, Karnataka, India

    Job Description Summary · This is a Lead Engineer position in Mechanical Systems Engg team. Activities aimed at proving a concept to be valid or technically feasible by the application of scientific and engineering methodologies. Work in this family typically has the objective of ...

  • Naukari Wale

    Lead Engineer

    5 days ago

    Naukari Wale Bangalore, India Full time

    Job Description : We are seeking a talented and experienced senior software engineer to join our dynamic team at dpdzero. · As a senior software engineer, you will play a crucial role in designing, developing, and maintaining our digital collections and recovery platform. · Your ...

  • Cropin

    Lead Engineer

    6 days ago

    Cropin bangalore, India

    Job Summary - · At least 8+ years of product development experience with expertise in designing and implementing high-performance applications for mobile (Android, iOS, Flutter) and web (good to have). Under the hood understanding of platforms and out of box thinking is the req ...

  • Tejas Networks

    Lead Engineer

    6 days ago

    Tejas Networks bangalore, India

    JD for Lead Engineer for POTP Software: · Experience and/or "hands on" working knowledge in the following areas: · Bachelors or master's degree in Electronics engineering or Computer Science.6 to 10 years of developing software experience in C/C++ on Linux based environment .Expe ...

  • ALP Consulting

    Lead Engineer

    6 days ago

    ALP Consulting bangalore, India

    Job Title: Lead Engineer (NodeJS Developer). · Hiring for Job in a Reputed Organization (Leading Product Based Company). · Here is a Gateway to it, through ALP Consulting. · Recruiting for Lead Engineer (NodeJS Developer). · Employment Type: Permanent. · Skills required: · - Prof ...

  • Kenvue

    Lead Engineer

    6 days ago

    Kenvue Bengaluru, India

    Kenvue GCC Bangalore · Lead Engineer · What You Will Do ? · As Observability engineers you are passionate about using software-based approaches to solve complex data-driven challenges and automate those solutions. You will lead efforts aimed at setting up enterprise observa ...