Software Engineer

2 weeks ago

Pune, Maharashtra, India IZiel Healthcare Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Company Description

IZiel Healthcare, with offices in the USA and India, specializes in providing Engineering, Software, and Regulatory Services for global medical device manufacturers. Equipped with expertise in Design for Six Sigma (Black Belt Level), our team delivers optimized product development processes using statistical and data-driven methodologies. Our services include systems engineering, software validation, risk management, QMS documentation, regulatory compliance, and process remediation for Class I, IIa, IIb, and III medical devices. IZiel Healthcare also offers client-centric training programs and has a strong track record in successfully managing regulatory approvals and technical challenges. We are committed to empowering organizations with innovative, efficient, and compliant solutions tailored to the healthcare industry.

Key Responsibilities

  • Support the preparation and maintenance of
    Technical Documentation
    in compliance with
    IEC 62304
    and
    IEC 82304
    standards for
    Software as a Medical Device (SaMD) and (SiMD)
    ,
    EU MDR
    ,
    FDA QSR (21 CFR 820)
    , and related regulatory requirements.
  • Contribute to the
    software development lifecycle documentation
    as per IEC 62304 and organizational quality processes.
  • Assist in defining and maintaining
    software risk management documentation
    aligned with
    ISO 14971
    and
    IEC 62304
    .
  • Collaborate with
    cross-functional teams
    (Development, Quality, and Regulatory) to ensure
    traceability, accuracy, and completeness
    of design and verification artifacts.
  • Review and update
    software lifecycle documentation
    , including
    requirements, architecture, verification, validation
    , and
    release records
    .
  • Ensure compliance with
    cybersecurity
    ,
    usability (IEC 62366)
    , and
    data integrity (21 CFR Part 11)
    requirements.

Required Skills

  • 1–5 years of experience in
    medical device software development
    or a
    regulated environment
    .
  • Strong understanding of
    IEC 62304
    ,
    ISO 13485
    ,
    ISO 14971
    , and
    IEC
    standards.
  • Hands-on experience with
    SiMD
    (Software in a Medical Device) and
    SaMD
    (Software as a Medical Device) documentation and regulatory submissions.
  • Excellent
    communication
    ,
    documentation
    , and
    cross-functional collaboration
    skills.

On Thursday 6th November 2025 @10:30AM

We would like to invite you for a face-to-face interview at our location. Please bring the following with you:

  1. A printed copy of your updated resume
  2. Your laptop

Looking forward to meeting you.

Interview location: IZiel Software Solutions
:-

C/o: Isprout Business Centre Pvt. Ltd Sakra World Hospital, 55/3 55/4,

Shilpitha Tech Park - Maithri Developers,

Devarabisanahalli Road Belandur, Kariyammana Agrahara,

Bengaluru Karnataka 560103

  • Software Engineer III

    6 days ago

    Pune, Maharashtra, India Rocket Software Full time

    It's fun to work in a company where people truly BELIEVE in what they're doingJob Description Summary:The Software Engineer-III designs, develops, troubleshoots, and debugs software programs for software enhancements and new products. Develops software tools including operating systems, compilers, routers, networks, utilities, databases, and Internet-related...

  • Software Engineer II

    2 weeks ago

    Pune, Maharashtra, India Rocket Software Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    It's fun to work in a company where people truly BELIEVE in what they're doingJob Description Summary:The Software Engineer-II designs, develops, troubleshoots, and debugs software programs for software enhancements and new products. Develops software tools including operating systems, compilers, routers, networks, utilities, databases, and Internet-related...

  • Senior Software Engineer

    19 hours ago

    Pune, Maharashtra, India Rishabh Software Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    About Rishabh Software:Rishabh Software, an India based IT service provider, focuses on cost-effective, qualitative and timely delivered Offshore Software Development, Recruitment Process Outsourcing (RPO) and Engineering Services.Our Core competency lies in developing customized software solutions using web-based and client/server technology. With over 25...

  • Senior Software Engineer

    7 days ago

    Pune, Maharashtra, India Perforce Software Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Perforce is a community of collaborative experts, problem solvers, and possibility seekers who believe work should be both challenging and fun. We are proud to inspire creativity, foster belonging, support collaboration, and encourage wellness. At Perforce, you'll work with and learn from some of the best and brightest in business. Before you know it, you'll...

  • Software Engineer

    1 week ago

    Pune, Maharashtra, India Momentive Software Full time ₹ 10,00,000 - ₹ 15,00,000 per year

    Job Description:Position OverviewWe are looking for Software Engineer to work within the Development team. This position will be in our Pune officePosition SummaryAs a Software Engineer, the associate will be responsible for orchestrating complex application development across the full lifecycle of development from concept to post-production support and...

  • Software Engineer

    7 days ago

    Pune, Maharashtra, India Momentive Software Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job Description:Position OverviewWe are looking for Software Engineer to work within the Development team. This position will be in our Pune officePosition SummaryAs a Software Engineer, the associate will be responsible for orchestrating complex application development across the full lifecycle of development from concept to post-production support and...

  • Manager, Software Engineering

    12 hours ago

    Pune, Maharashtra, India Perforce Software Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Perforce is a community of collaborative experts, problem solvers, and possibility seekers who believe work should be both challenging and fun. We are proud to inspire creativity, foster belonging, support collaboration, and encourage wellness. At Perforce, you'll work with and learn from some of the best and brightest in business. Before you know it, you'll...

  • Senior Software Engineer

    2 weeks ago

    Pune, Maharashtra, India Momentive Software Full time ₹ 1,20,000 - ₹ 3,00,000 per year

    Job Description:Position OverviewWe are looking for Senior Software Engineer to work within the Development team. This position will be in our Pune officePosition SummaryAs a Senior Software Engineer, the associate will be responsible for orchestrating complex application development across the full lifecycle of development from concept to post-production...

  • Software Engineer

    3 days ago

    Pune, Maharashtra, India Perforce Software Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Perforce is a community of collaborative experts, problem solvers, and possibility seekers who believe work should be both challenging and fun. We are proud to inspire creativity, foster belonging, support collaboration, and encourage wellness. At Perforce, you'll work with and learn from some of the best and brightest in business. Before you know it, you'll...

  • Lead Software Engineer

    5 days ago

    Pune, Maharashtra, India Coupa Software Full time ₹ 20,00,000 - ₹ 60,00,000 per year

    Coupa makes margins multiply through its community-generated AI and industry-leading total spend management platform for businesses large and small. Coupa AI is informed by trillions of dollars of direct and indirect spend data across a global network of 10M+ buyers and suppliers. We empower you with the ability to predict, prescribe, and automate smarter,...