11+ ISO 13485 Jobs in Bangalore (Bengaluru) | ISO 13485 Job openings in Bangalore (Bengaluru)

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

The candidate should have extensive experience in designing and developing scalable data pipelines and real-time data processing solutions. As a key member of the team, the Senior Data Engineer will play a critical role in building end-to-end data workflows, supporting machine learning model deployment, and driving MLOps practices in a fast-paced, agile environment. Strong expertise in Apache Kafka, Apache Flink, AWS SageMaker, and Terraform is essential. Additional experience with infrastructure automation and CI/CD for ML models is a significant advantage.

Key Responsibilities

1. Design, develop, and maintain high-performance ETL and real-time data pipelines using Apache Kafka and Apache Flink.
2. Build scalable and automated MLOps pipelines for training, validation, and deployment of models using AWS SageMaker and associated services.
3. Implement and manage Infrastructure as Code (IaC) using Terraform to provision and manage AWS environments.
4. Collaborate with data scientists, ML engineers, and DevOps teams to streamline model deployment workflows and ensure reliable production delivery.
5. Optimize data storage and retrieval strategies for large-scale structured and unstructured datasets.
6. Develop data transformation logic and integrate data from various internal and external sources into data lakes and warehouses.
7. Monitor, troubleshoot, and enhance performance of data systems in a cloud-native, fast-evolving production setup.
8. Ensure adherence to data governance, privacy, and security standards across all data handling activities.
9. Document data engineering solutions and workflows to facilitate cross-functional understanding and ongoing maintenance.

Responsibilities:

• Understanding the flow of code and how it interacts with different components.
• Understanding project documents, customer demands, and product objectives to create and execute test cases.
• Setting up, maintaining, and performing test automation frameworks on multiple application platforms, such as Mobile, Desktop, and Web, and building test scenarios and acceptance tests.
• Investigating customer problems referred to you by the technical support team, testing bugs, and creating and managing bug reports.
• Handling technical communications and understanding the customers' systems.
• Working with deployments teams, resolving level issues for systems, coordinating on product design, and offering inputs on the testability of functional elements and product designs.
• Noting all testing actions you have performed in daily and weekly reports.
• Analyzing and disintegrating software systems and coordinating with other teams to enhance the overall design.
• Researching test tools, methodologies, and trends and upgrading existing practices and processes.
• Managing the final quality on production release.

Eligibility Criteria:

Exp- 4-7 years

Notice period- Currently Serving

Mode of Work- Hybrid

Must have skills:

1. Should have good hands on Java (spring, DSA and Problem Solving)
2. Experience in API Testing- Rest Assured
3. Experience in Selenium

Role

Being a part of the Products / Software Engineering team, this member is expected to work with the existing development team. Key responsibilities of this role include MS Tech stack-based applications as per the product roadmap / project scope. Coordinate with co-developers and contribute to all phases of the development lifecycle.

Experience

Around 4 years of experience in creating and implementing Web-based applications using

C#, ASP.net, Web API, MVC, Micro Services, JavaScript and SQL Server.

Familiarity or exposure to CI / CD, Dev Ops such as Dockers, containers, Azure, Pipeline is

highly recommended

Ability to work in an Agile, fast-paced environment, and learn rapidly.

Bachelor degree in computer science, computer engineering or similar.

Familiar with object-oriented development, design patterns and specifically in .NET

Framework (C#) with a strong background in web-based development and service-oriented

Architecture.

Expert in HTML, CSS, JavaScript, JQuery, JSON.

Writing clean, readable, and easily maintainable code.

Must have knowledge of project/task management tools like Jira,

Familiarity with Version Control like Bitbucket, Git etc.

Understanding of UI, cross-browser compatibility and web standards.

Build features and applications with responsive design

Good English communication skills, written and spoken.

Able to work with minimum supervision as well as perform under pressure and meet

Deadlines.

Job Description:

• Strong working experience in IOS application development is a must. First-hand experience of native mobile apps using Swift must.
• Experience with Swift, RxSwift, Swift UI, Unit test.
• Strong system design and architecture skills - specifically for IOS. Curiosity to tinker around, explore new paradigms and strongest for continuous improvement. Strong problem-solving skills.
• Understanding of network connections, Rest API'sand scheduling. Strong knowledge about security standards (e.g. HTTPS) and privacy standards.
• Idea/experience of the unit and instrumentation testing in IOS. Optimizing app performance and memory consumption.
• Leveraging community libraries to efficiently complete development tasks.
• Debugging apps using simulators and related tooling.
• Persisting data for offline-first apps using databases such as Realm.
• Localizing apps to support multiple languages and regions, vernacular libraries and fonts.
• Familiar with Version control system such as GIT.

                                                        Business Development Manager- Job Description

Responsibilities

• Lead generation through various marketing activities, cold call and networking.
• Meet potential clients by growing, maintaining, and leveraging your network.
• Developing sales plan, prospecting / identification of opportunities, customer presentations, managing RFI / RFP responses, and winning opportunities.
• Achieve set targets in terms of revenue, profitability, collection and other result areas.
• Work with technical team and other internal colleagues to meet customer needs.
• Arrange and participate in internal and external client debriefs.

• Manage Key Accounts, develop and maintain client relationship.
• New Account Development, Developing relationships with key decision-makers in target organizations for business development.
• Understanding and coordinating client's needs / enhancements and consulting with team to provide solutions in adherence to delivery schedules.

 Skill Sets

• Knowledge of IT Infrastructure Solutions and Services.
• Knowledge of Networking products like Switches, Routers, structured cabling , NAS SAN Storage, CCTV etc.

• Knowledge of of IT Security products like UTM, firewall, VA-PT Cyber Security and End Point Security.

• Knowledge of Computing like Servers, Desktops etc.

 Requirements

• Technical Background (BE, B.Tech, B Sc, BCA, B.com, Diploma) MBA a strong plus.
• Good track record in IT Hardware, Software & Services sales.
• 3 to 12 years of Corporate Sales experience in IT Industry mandatory. 
• Excellent interpersonal, diplomacy and conflict-resolution skills.
• Good Personal Networking Skills.

Position :- Automation Test Engineer – Selenium using C#

Location :- Bangalore

Experience:- 3-6years

Job Description

3+ years of Experience in Test Automation using Selenium, C#
BDD (Behavioral driven Development) is a must, using either Specflow.
Creating, Organizing, and managing Test Automation Resources.
Creating, Enhancing, debugging and Running Test Scripts.
Organizing, monitoring defect management process.
Finding solutions for Object Identification issues and error handling issues.

Primary Skills - Testing - Automation - Mastery, Javascript - Skill, Testing - E2E - Skill Job Description: - JD as below, 4+ years of Experience in Test Automation using Selenium BDD (Behavioral driven Development) C# is a must, using Specflow. Creating, Organizing, and managing Test Automation Resources. Creating, Enhancing, debugging and Running Test Scripts. Organizing, monitoring defect management process. Finding solutions for Object Identification issues and error handling issues.