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 Title : GxP Manual Functional Tester

Experience Required : 5.5 to 7 years

Work Mode : Hybrid

Location : PAN India (excluding Salem, Coimbatore, and Gandhinagar)

Notice Period : Immediate joiners preferred

Job Description :

We are looking for a skilled GxP Manual Functional Tester with strong experience in manual testing within GxP-compliant environments.

The ideal candidate will have a solid understanding of the software testing lifecycle and hands-on experience in Functional, FIT, and UAT testing. You will work closely with cross-functional teams, including business, development, and regulatory stakeholders, in an Agile setup.

Mandatory Skills : Manual Testing, GxP Compliance, STLC, FIT & UAT Test Design, Agile Testing, Jira, Defect Management, and Test Documentation.

Key Responsibilities :

• Perform manual testing in GxP-regulated environments ensuring compliance with regulatory standards.
• Design and execute Functional Integration Testing (FIT) test cases.
• Prepare and perform User Acceptance Testing (UAT) test scenarios.
• Participate in Agile incremental testing cycles.
• Track, report, and manage defects using Jira or similar test management tools.
• Collaborate with development, QA, regulatory, and business teams to ensure effective communication and accurate documentation.
• Maintain detailed testing documentation and contribute to continuous test process improvements.

Required Skills :

• Minimum 4+ Years of experience in manual testing in GxP-compliant environments.
• Strong knowledge of STLC, SDLC, and Agile methodologies.
• Hands-on experience in FIT test case design and execution.
• Expertise in UAT test design and coordination.
• Experience with test management tools such as Jira.
• Excellent communication and documentation skills.
• Strong defect management capabilities.

Note :

• This is a hybrid role; candidates must be willing to work from a Capgemini office as required.
• Remote-only profiles will not be considered.
• Locations not accepted: Salem, Coimbatore, Gandhinagar.

·       Conduct telecalling and cold calling to potential clients (target: 50 calls per day).

·       Generate new business leads, especially MNCs or corporates planning expansion, relocation, or renovation of their office spaces.

·       Maintain and update lead databases and contact lists in Excel or CRM tools.

·       Conduct online research to identify new companies, decision-makers, and opportunities in target markets.

·       Coordinate with the design and project teams to share qualified leads for proposal preparation.

·       Record and update all client communications, follow-ups, and meeting schedules systematically.

·       Prepare and submit regular reports on lead generation activities and progress.

Support marketing and business outreach campaigns.

• Core Java: advanced level competency, should have worked on projects with core Java development.

• Linux shell : advanced level competency, work experience with Linux shell scripting, knowledge and experience to use important shell commands

• Rdbms, SQL: advanced level competency, Should have expertise in SQL query language syntax, should be well versed with aggregations, joins of SQL query language.

• Data structures and problem solving: should have ability to use appropriate data structure.

• AWS cloud : Good to have experience with aws serverless toolset along with aws infra

• Data Engineering ecosystem : Good to have experience and knowledge of data engineering, ETL, data warehouse (any toolset)

• Hadoop, HDFS, YARN : Should have introduction to internal working of these toolsets

• HIVE, MapReduce, Spark: Good to have experience developing transformations using hive queries, MapReduce job implementation and Spark Job Implementation. Spark implementation in Scala will be plus point.

• Airflow, Oozie, Sqoop, Zookeeper, Kafka: Good to have knowledge about purpose and working of these technology toolsets. Working experience will be a plus point here.

Oddr is looking for a skilled backend engineer to help us build scalable multi-tenanted enterprise Cloud applications. The ideal candidate should be able to bring new ideas to the table and design and develop distributed microservices with a strong emphasis on security, resiliency, scalability, performance, and quality. The candidate should be a self-motivated team player and take pride in what they deliver.

The candidate should be interested in a long-term stable career to grow with our company. The candidate will need to work late night hours because of the geographic distribution of the team.

Requirements:

• Strong understanding of .NET Core and C#
• Knowledge of Cloud development concepts
• Experience with successful end-to-end delivery of web applications in the Cloud. Azure knowledge is a strong plus.
• Experience with API-driven development and developing RESTful APIs
• Experience with database design and writing complex SQL
• Ability to write clean, well-structured code with adequate test coverage, proper abstraction, and reusability
• Ability to work to tight deadlines, manage priorities, and take responsibility for delivering to time and quality requirements
• Good understanding and experience with Agile development methodologies
• Excellent communication skills
• Excellent problem-solving skills

Minimum qualifications required:

• Bachelor's degree or relevant certification from a reputable institute.
• 3-5 years of experience.

Duties/ Responsibilities

• Performing exhaustive research to gain in-depth knowledge of all customer personas
• Creating specifications and content appropriate for the brand's customer personas
• Planning the editorial calendar and content proposition
• Developing content governance guidelines for tone, style, and voice of all content, and ensuring they are followed
• This role is 50/50 conceptualizing and executing. You must be able to not only ideate and pitch your own create concepts to your peers and management, but also work with a team to execute others’ ideas when needed.
  
  Collaborate as part of a small, agile video team producing original video content for digital platforms from script to shoot to edit and delivery.
  
  Create content for social channels, with a clear understanding of how users engage with social creative across formats and platforms.
  
  Develop best practices and expertise around creating, publishing and distributing videos specific to various digital platforms, and train teammates in those best practices.
  
  Qualifications / Skills :
  
  5+ years of experience in a creative agency, production company, or in-house at a brand pitching and editing video content for social and digital channels.
  
  Should have a proven track record of creating content for a company/ Individual.
  
  Detail-oriented, fast learner, and able to manage your own time.
  
  Can effectively cope with change, shift gears comfortably, decide and act without having the total picture. Cut your own way through ambiguity and engaging management smartly when needed.

Benefits:

• This is a full time position, working from office. Office Address: Lexicon International School, Kalyani nagar, Pune.
• Transportation reimbursement is available.
• Medical Insurance available.
• Leadership & Development training for all manager-level employees
• Salary will be as per the skills and the experience of the applicant.

 Job Title: Urgent opening - Web/front-end React.JS/Vue.JS  Developer 

Job Location: Baner, Pune 

Experience: 2 to 6 years 

Notice Period: 1 Month or Less  

Annual CTC: 400000 - 1500000 INR 

Skills: HTML5, CSS3, AJAX/JavaScript/JQuery, Bootstrap, Angular JS/ Rect.JS/ Vue.js, Bit-bucket, Git /GitHub 

Technical Requirements: 

• Technical know-how from both coding & design perspective - Bootstrap grid, Material design guidelines, HTML5, CSS3, JS, etc 
    
• In depth expertise and hands on experience with Front End Development technologies like Angular, Bootstrap and React.Js / Vue.Js etc. 
    
• In depth expertise and hands on experience with Designing Web Applications using programming languages such as HTML5, CSS3, JS, JQuery and API’s.  
    
• Strong understanding of UI requirements, cross-browser compatibility requirements, general web functions and other standards. 
    
• Experience with basic Architectures like MVC and MVVM 

• Comfort in working in short, agile, iterative development cycles 
   

Roles and Responsibilities: 

•  The candidate should take ownership of the assigned work from both UI and backend development standpoint. 
    
• The candidate should be able to understand client requirements and come back with Design as well as Technical specs and should be able to estimate requirements at lower level. 
    

• Should be able to visualize and create wireframes, storyboards, user flows, process flows and logic diagrams to communicate interaction and design ideas. 
    
• Should experiment on upcoming trends on coding, designing and implementing it during development. 
    
• Should have seamless and fluent communication, learning attitude and analytical nature. 
    
• Should be a problem solver with an attitude to contribute towards the success of Team/Project as well as organisation. 
    
• Should be able to guide other members in the team 
    
• Should take initiatives to improve code quality standards and team efficiency. 
    
• Should be able to Participate in the requirements gathering and come up with efficient solutions 
    
• Should be able to Efficiently estimate on high and low level along with assessing risk items