11+ FDA Jobs in Pune | FDA Job openings in Pune

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.

Job Description

We are looking for a skilled Flutter Developer with a minimum of 2+ years of experience and expertise in the BLoC (Business Logic Component) architecture to join our development team. You will be responsible for building high-quality mobile applications for both Android and iOS, ensuring robust performance, and providing a seamless user experience.

Responsibilities

- Design, develop, and maintain mobile applications using Flutter and Dart.

- Implement and manage state using the BLoC architecture.

- Collaborate with cross-functional teams to define, design, and ship new features.

- Ensure code quality by writing clean, maintainable, and testable code.

- Optimize application performance, identify and fix bugs, and enhance application responsiveness.

- Integrate RESTful APIs and other backend services.

- Participate in code reviews and provide constructive feedback to team members.

Requirements

- Minimum of 2+ years of experience as a Flutter Developer.

- Strong knowledge of Dart and Flutter framework.

- Proficiency in using the BLoC architecture for state management in Flutter applications.

- Experience with third-party libraries and APIs.

- Familiarity with RESTful APIs, JSON, and web services.

- Understanding of the mobile development lifecycle and app store guidelines for both iOS and Android.

- Proven experience in publishing a minimum of 2 mobile applications to the Apple App Store and Google Play Store.

- Knowledge of version control systems like Git.

- Strong problem-solving skills and attention to detail.

Preferred Skills

- Experience with Flutter for the web.

- Familiarity with other state management techniques in Flutter, like Provider, Riverpod, etc.

- Experience with CI/CD tools and practices.

- Knowledge of agile development methodologies.

- Strong communication and teamwork skills.

Key Responsibilities

• Architect and maintain scalable end-to-end automation frameworks using Playwright and TypeScript to ensure high test coverage and reliability across complex web applications.
• Design and execute advanced SQL queries in PostgreSQL to perform backend data validation, ensuring data integrity and consistency between the UI and database layers.
• Apply robust system design principles to develop modular, reusable test components and service-level abstractions that minimize framework technical debt.
• Integrate automated test suites into CI/CD pipelines to facilitate continuous testing and provide rapid feedback on build stability and regression impacts.
• Collaborate with cross-functional engineering teams to conduct technical design reviews, identifying potential edge cases and architectural risks early in the SDLC.
• Mentor junior quality engineers on best practices for asynchronous programming in TypeScript and efficient selector strategies within the Playwright ecosystem.
• Analyze complex system requirements to create comprehensive test strategies that balance functional automation with performance and reliability benchmarks.

Success Metrics for this Role (first 6 months):

• Achieve maximum possible automation coverage for all high-priority regression test cases within the assigned functional module using Playwright and TypeScript.
• Reduce manual regression testing execution time by at least 40% through the implementation of optimized, parallelized test scripts and CI/CD integration.
• Design and implement a minimum of 5 complex utility functions or custom hooks in the Playwright framework to enhance code reusability and handle intricate PostgreSQL data validation workflows.
• Maintain a script stability rate of 90% or higher, ensuring that failures are due to genuine application defects rather than environment instability or flaky test logic.

Good-to-Have / Preferred Skills

• Proficiency in implementing and managing Continuous Integration and Continuous Deployment pipelines using tools like GitHub Actions, GitLab CI, or Jenkins.
• Experience with Docker and containerization strategies to ensure consistent execution of test suites across various environments.
• Understanding of cloud infrastructure services, specifically AWS or Azure, for scaling automated test execution and managing cloud-native databases.
• Mastery of API contract testing frameworks like Pact to ensure service compatibility within microservices architectures.

Have a good understanding and experience in IT Recruitment

Experience handling Vendor Management

Co-ordination with the Client for their requirement

Co-ordination, sorting, and sourcing, candidates as per Client’s requirements

Mailing and coordination

Crafting recruiting emails to attract passive candidates.

Design and update job descriptions

Screen incoming resumes and applications and forms

Source and recruit candidates by using databases, social media, etc.

C2H Role - 6 months

Location: Pune (Work from home till Pandemic)

Skills: Java, Spring, Hibernate, MySQL,

Backend Skills – Java Spring Boot, JSP, MySQL, Document DB

Frontend Skills – ReactJS

Good to have ( Not Mandatory ) – Python.

Job Description:

• Hands on experience in designing and developing applications using Java
• Hands on experience in Spring, Hibernate, Micro-Services and MySQL
• Object Oriented analysis and design using common design patterns.
• Familiarity with build tools like Maven
• Proficient understanding of code versioning tools, such as Git
• Experience in Java Development
• Good to have experience or Basic knowledge in ReactJs but not mandatory

We are looking for a Senior Test Engineer who will work closely with the project team members and ensure the quality of the delivery.

• Develop automated tests for product validation (regression and integration).
• Develop and execute test cases, scripts, plans, and procedures (manual and automated).
• Integrate and execute automated tests in CI/CD environments
• Troubleshoot, and improve existing automation scripts
• Act as a lead team member as the team grows, providing support and training to other team members
• Execute test cases against various software applications and document the results
• Perform ad hoc testing of new and existing features to ensure they meet design requirements, quality,

    and usability standards

• Follow-up with and document resolution of bugs
• Maintain test cases for manual and automated tests
• Communicate defects to stakeholders in a clear and concise manner

• Minimum 3 - 5 years experience in a diverse technology environment in a Quality Assurance role
• Experience developing testing strategies and test plans
• Experience creating and executing automated end-to-end tests, using tools such as Selenium,

    Cucumber, or other automation frameworks

• Exposure to ‘Leapwork’ is good to have. Expertise on Java, OOPS Concepts
• Good understanding of software development lifecycles
• Ability to work in multiple application environments

Strong data analysis, data verification, and problem-solving abilities

• Fluency in written and communication skills in English
• Strong ability to work collaboratively in a team environment
• Excellent organizational skills including, management of multiple assignments, setting personal goals and

    targets, and document management

• Excellent focus on detail through adherence to quality assurance best practices