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:

• Design and develop automated test scripts using Java and Selenium.
• Implement BDD frameworks using Cucumber.
• Perform API testing using tools like Postman, RestAssured, or similar.
• Collaborate with cross-functional teams to define, design, and ship new features.
• Identify and correct bottlenecks and fix bugs.
• Help maintain code quality, organization, and automation.
• Write unit and integration tests to ensure the design criteria are met.
• Produce well-written documentation for each test case.

Role Description:

This is a full-time on-site role for an Angular Developer, located in Pune. The Angular Developer will be responsible for front-end web development, software development. The candidate should be proficient in Angular, .NET Core and JavaScript.

Education:

A bachelor's degree in Computer Science, Software Engineering, or a related field relevant certification is typically required. Candidates with equivalent 3-6 years’ experience will be consider.

Experience- 4 to 10 yrs

Location: Pune, India (WFO)

Immediate joiners are preferred (urgent requirement).

Technical Skills:

Proficiency in Angular, .NET, TypeScript and JavaScript is essential. Experience with modern JavaScript frameworks and libraries such as React, Angular, or Vue.js is often required.

Knowledge of server-side languages such as Angular, Node.js, Java (Spring), or PHP (Laravel) is important.

Familiarity with database systems such as MySQL, PostgreSQL.

Understanding of database design principles and SQL/NoSQL querying.

Proficiency with version control systems like Git is usually required.

Experience in designing and consuming RESTful APIs, as well as understanding of HTTP protocols.

Familiarity with development tools and platforms such as IDEs (Visual Studio Code, IntelliJ IDEA), package managers (npm, yarn), and build tools (Webpack, Grunt, Gulp).

Knowledge of testing frameworks and debugging techniques.

Understanding of containerization (Docker), deployment pipelines, and

continuous integration/continuous deployment (CI/CD) practices (Deployment and DevOps).

Experience:

Demonstrated experience in both frontend and backend development, with the ability to work on the entire stack.

Previous experience in developing web applications, from conceptualization to deployment.

Ability to solve complex technical problems and debug issues efficiently.

Experience working in collaborative environments, including Agile methodologies and version control systems.

Experience in IT Healthcare will be prefer.

Soft Skills:

Strong verbal and written communication skills are essential for collaborating with team members and conveying

technical concepts to non-technical stakeholders.

Ability to adapt to new technologies, frameworks, and project requirements.

Team Player Willingness to work in a team environment, share knowledge,

and mentor junior developers.

Thoroughness in code reviews, testing, and documentation.

Our client is a rapid growth stage Edtech start-up focused on solving the teacher shortage crisis in the US education system using technology by bringing teachers to the classrooms and giving them access to the right tools to teach students in a highly engaging manner.

They have a development center in Mumbai and they are looking to scale up the teams in Pune and Bangalore as well.

What does the role entail:

●Lead requirement/task and guide junior software engineers in the development process.

● Design, develop and maintain user interfaces for web and mobile applications.

● Strong understanding of UI design principles and best practices.

● Collaborate with cross-functional teams to analyse requirements, design solutions, and implement new features.

● Develop and implement unit tests and integration tests to ensure software quality.

● Troubleshoot and debug applications.

● Participate in code reviews and provide constructive feedback to peers.

● Mentor junior software engineers and help them grow their technical skills.

Required Skills:

● B.E/B.Tech/master’s in computer science (or equivalent).

● 4 - 7 years of experience

● Skilled with one of Front end Technologies: Angular 10+/Flutter/React/Vue.

● Experience with HTML, CSS, JavaScript, and TypeScript or Dart.

● Experience with state management libraries.

● Experience with UI testing frameworks such as Cypress.

● Experience with responsive design and developing mobile-first user interfaces.

● Knowledge of UI accessibility guidelines and experience implementing accessibility features.

● Excellent problem-solving, critical thinking, and communication skills.

● General understanding of Agile software development methodologies.

● Understanding of development and operational support best practices.

We are looking for a dynamic and self-driven sales representative to join our team. As a SaaS Sales Representative, you will be responsible for driving sales of our recruitment software to new and existing customers. You will identify and qualify leads, create and deliver persuasive sales presentations, and close deals to meet and exceed sales targets.

Key responsibilities:

1. - Identify and qualify potential customers through a variety of methods, including outbound calls, emails, and social media outreach
2. - Understand customer needs and provide solutions through the use of our recruitment software
3. - Create and deliver compelling sales presentations to potential customers, highlighting the benefits and features of our software
4. - Negotiate and close deals with potential customers
5. - Meet and exceed sales targets on a monthly and quarterly basis
6. - Keep up-to-date with industry trends and competitive products

Qualifications:

• - 1- 4 years of experience in a SaaS sales role
• - Proven track record of meeting or exceeding sales targets
• - Excellent communication and presentation skills
• - Ability to build and maintain strong relationships with customers
• - Ability to work independently and as part of a team
• - Experience with CRM software (e.g., Salesforce) is a plus
• - Experience in the recruitment industry is a plus, but not required

If this sounds like a good fit for you, please apply with your resume and a cover letter explaining why you are interested in this role. We look forward to hearing from you!

• Preparing Scope of Work and Project Plans for the Solution.
• Preparing High Level & Low Level designs as per proposed Solution.
• Design and Implementation of Routing and Switching technologies.
• Design and implementation of Data Centers on SDN technologies e.g. Cisco ACI, VMware NSX.
• Campus LAN and Wireless design, Implementation and Troubleshooting.
• Design and implementation of software defined campus network e.g. Cisco DNA, SD-Access
• Design, Implementation of WAN, and SDWAN Technologies.
• Hands on experience on WAN optimization technologies.
• Troubleshooting and repairing network issues, as well as developing, applying
• Hands on experience on WAN optimization technologies.
• Troubleshooting and repairing network issues, as well as developing, applying and enforcing best practices and policies
• Monitoring and performing routine tests on an assigned system and reporting results.
• Identifying opportunities for continuous improvements
• Contributing and producing regular status reports as required
• Provide resolution to project or customer issues, following proper escalation procedures, in a timely fashion
• Create project documentation and procedures
• Excellent communication (written and oral) and interpersonal skills
• Knowledge and experience of ITIL based service processes: Incident Management, Change Management, Release Management, Problem Management, etc.

Expectations:

The candidate is expected to work on 3D Graphics and asset creation for Augmented Reality and Mixed Reality apps for iOS, Android and Hololens. Job includes - starting from understanding of the requirements to develop & deliver 3D data to developers developing the apps. Candidate should have good visualization skills with creative bent of mind. Candidate should have professional experience in producing 3D models and animations using 3DS Max, Maya , Unity 3D, Zbrush and Photoshop for the in-game world. Looking for creative individuals with good design flair.

Responsibilities:

· Creates, builds and maintains computer generated 3D models of story elements and designs that meet the art direction and requirements

· High quality photorealistic 3D rendering and animation

· Proficient in optimizing 3D assets

· Experience working on rigging, unwrapping and visual effects

· Should have experience in creating photorealistic textures & post-processing skills

· Expertized in Video Editing, Motion Graphics & E-Learning

· Proficient in visual storytelling through engaging videos

· Accountable for meeting productivity and targets

· Conceptualize artwork, scene, composition based on a solid understanding of content and project needs

· Translate conceptual sketches into delightful and accurate 3D art illustrations.

· Translate static hand-sketches into high fidelity artwork and eventually animations / videos that are in sync with voice-over/music following strict subject matter, storyboard descriptions.

· Iterate sketches and art mockups quickly on ideas that are still in the process of being defined.

Requirement:

· Any graduation and/or Certification from a reputed 3D design / animation institute

· Strong knowledge on 3D Studio Max, Maya and Unity

· Good visualization skills with creative bent of mind

· Proficient in character design and background design with a good sense of colour palette

· Understanding of 3D concepts, ability to visualise 3-dimensions

• This is mainly a full stack position .net or Java experience
• Full Stack Experience in Angular 5+ along with Dot Net is preferred
• Dot Net experience in C#,Entity framework in Postgre SQL,Restful web services,Azure and AWS cloud solutions,HTML5,CSS3,JavaScript and Bootstrap and Angular