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 Position: Lead II - Software Engineering

Domain: Information technology (IT)

Location: India - Thiruvananthapuram

Salary: Best in Industry

Job Positions: 1

Experience: 8 - 12 Years

Skills: .Net, Sql Azure, Rest Api, Vue.Js

Notice Period: Immediate – 30 Days

Job Summary:

We are looking for a highly skilled Senior .NET Developer with a minimum of 7 years of experience across the full software development lifecycle, including post-live support. The ideal candidate will have a strong background in .NET backend API development, Agile methodologies, and Cloud infrastructure (preferably Azure). You will play a key role in solution design, development, DevOps pipeline enhancement, and mentoring junior engineers.

Key Responsibilities:

• Design, develop, and maintain scalable and secure .NET backend APIs.
• Collaborate with product owners and stakeholders to understand requirements and translate them into technical solutions.
• Lead and contribute to Agile software delivery processes (Scrum, Kanban).
• Develop and improve CI/CD pipelines and support release cadence targets, using Infrastructure as Code tools (e.g., Terraform).
• Provide post-live support, troubleshooting, and issue resolution as part of full lifecycle responsibilities.
• Implement unit and integration testing to ensure code quality and system stability.
• Work closely with DevOps and cloud engineering teams to manage deployments on Azure (Web Apps, Container Apps, Functions, SQL).
• Contribute to front-end components when necessary, leveraging HTML, CSS, and JavaScript UI frameworks.
• Mentor and coach engineers within a co-located or distributed team environment.
• Maintain best practices in code versioning, testing, and documentation.

Mandatory Skills:

• 7+ years of .NET development experience, including API design and development
• Strong experience with Azure Cloud services, including:
• Web/Container Apps
• Azure Functions
• Azure SQL Server
• Solid understanding of Agile development methodologies (Scrum/Kanban)
• Experience in CI/CD pipeline design and implementation
• Proficient in Infrastructure as Code (IaC) – preferably Terraform
• Strong knowledge of RESTful services and JSON-based APIs
• Experience with unit and integration testing techniques
• Source control using Git
• Strong understanding of HTML, CSS, and cross-browser compatibility

Good-to-Have Skills:

• Experience with Kubernetes and Docker
• Knowledge of JavaScript UI frameworks, ideally Vue.js
• Familiarity with JIRA and Agile project tracking tools
• Exposure to Database as a Service (DBaaS) and Platform as a Service (PaaS) concepts
• Experience mentoring or coaching junior developers
• Strong problem-solving and communication skills

JOB PURPOSE   

A Senior Associate Java WCS Technologist is considered as a senior contributor for complex modules of work by bringing deep core technology expertise and relevant business subject matter expertise to the table.  

JOB RESPONSIBILITIES   

• Sr. Associate, Technology plays a significant role during the design and implementation of the technological solution for our clients.   
• A Sr. Associate, Technology is involved in ensuring a quality technical design that satisfies the business requirements of the client.   

• A Sr. Associate, Technology is often involved in package evaluations and recommendations, communicating the technological details of the project to the business users and workshops with the clients. Sr. Associate, Technology also participates in gathering business requirements and assessing existing architectures and resources.  
• Sr. Associate, Technology provides leadership to the team by taking responsibility for a specific component or track of the project architecture.  By taking on this level of responsibility, a Sr. Associate, Technology spends more time overseeing the tasks required to implement a solution rather than performing the tasks directly.  This includes planning, estimation, resource management, issue resolution and quality assurance.  A Sr. Associate, Technology is also responsible for coordinating and communicating with the other tracks and disciplines involved in the project.   
• In performing the essential functions of this role, the work is fast-paced, moderately noisy and team-based.  Additionally, frequent overnight travel is required.  
• Prepares the technical design of the more complex technology components within the module (one or more of client/web presentation tier, server tier, data access and data model, integration component, package function customization)  
• Participates in and in some cases drives design reviews of other modules and provides insightful comments to improve the design quality and design conformance to standards  

• Assists the architect in articulating the pros and cons of using a certain technology stack/package or component or design pattern versus another to the clients and project team and drives selection of technologies, designs to come up with the optimal architecture  
• Implements slice of application (EAR) and proofs of concept (spike solution) to prove any new technologies or integration scenarios in the module  
• For package implementations, aids the Architect of the project to perform the gap analysis between business requirements and the package features and design the configuration, customizations, extensions, interfaces required to meet the requirements  
• Provides innovative solutions to project level technical issues  
• Critiques a design created by another designer and helps identify design and performance improvements  

• Interacts with a set of clients (client senior developers and architects) to create technology specifications from business requirements for one of the modules within the project  
• In some scenarios, collaborates with client developers to design, build, test and deploy the module components and integrate with the rest of the modules  
• Raises and drives to closure with the client any technical design and implementation issues in the module and also in the interfaces and interactions with other modules  
• Estimates the implementation and deployment of the module based on design architecture, testing strategy and overall project plan  
• Assists the architect in coming up with the overall estimates for the project along with any key risks and issues and their mitigation  

• Reports progress and issues to the Manager in a timely manner. In particular, to relay issues that might impact on quality or the ability to deliver to timescales or estimates  
• Works with team on the development of standards, processes and procedures related to application security, upgrade management, capacity planning, application deployment, performance monitoring/tuning, and failover and disaster recovery  
• Mentors the team on the best techniques to debug and troubleshoot design and implementation defects and issues  
• Shares point of view on technology stack, package and latest technology and business trends in one or more relevant areas (e.g. eCommerce, Content Management).  
• Documents the technical design using UML, suitable design patterns in the form of technical design narrative, object models, sequence diagrams, collaboration diagrams  

SKILL REQUIREMENTS  

Experience in: J2EE - Application Servers, Java - ORM, Java - Spring Framework, Core  

Java, SQL Development Languages, Java - Web, Presentation Frameworks, Java - Messaging  

Implementation, Java Web Services, Planning/ Execution & Tracking, Scoping and  

Estimating, Data Modeling, High Availability and Failover Applications, High Throughput / Transaction Application, Logical Architecture Design, OOAD and UML, Package / Vendor Selection, Performance / Capacity Planning, Application, Security.  

Ability to abstract detail into larger (repeatable) patterns, familiarity with user centered analysis and evaluation techniques   

Understanding of the project life cycle process to effectively be able to manage a sub- 

Business Knowledge:  Domain experience on Enterprise data warehouse would be a plus.  

Personal Attributes: a. Strong and innovative approach to problem solving and finding solutions b. Excellent communicator (written and verbal, formal and informal) c. Flexible and proactive/self-motivated working style with strong personal ownership of problem resolution d. Ability to multi-task under pressure and work independently with minimal supervision. e. Ability to prioritize when under pressure  

EXPERIENCE   

2-8 years  

EDUCATION  

Full Time Bachelor’s / Master’s degree (Science or Engineering preferred)  

About Company:

Our client is the industry-leading provider of CRM messaging solutions. As a forward-thinking global company, it continues to innovate and develop cutting-edge solutions that redefine how businesses digitally communicate with their customers. It works with 2500 customers across 190 countries with customers ranging from SMBs to large global enterprises.

About the role:

The Director of Product Management is responsible for overseeing and implementing product development policies, objectives, and initiatives as well as leading research for new products, product enhancements, and product design.

Roles & responsibilities:

- Become a product expert on all company's solutions

- Build and own the product roadmap and timeline.

- Develop and execute a go-to-market strategy that addresses product, pricing, messaging, competitive positioning, product launch and promotion.

- Work with Development leaders to oversee development resources, including managing ROI, timelines, and deliverables.

- Work with the leadership team on driving product strategy, in both new and existing products, to increase overall market share, revenue and customer loyalty.

- Implement and communicate the strategic and technical direction for the department.

- Engage directly with customers to understand market needs and product requirements.

- Develop/implement a suite of Key Performance Indicators (KPI's) to measure product performance including profitability, customer satisfaction metrics, compliance, and delivery efficiency.

- Define and measure value of software solutions to establish and quantify customer ROI.

- Represent the company by visiting customers to solicit feedback on company products and services.

- Monitors and reports progress of projects within agreed upon timeframes.

- Write very high quality BRD, PRDs, Epics and User Stories

- Creates functional strategies and specific objectives as well as develops budgets, policies, and procedures.

- Creates and analyzes financial proposals related to product development and provides supporting content showing allocation of funds to execute these plans.

- Write status updates, iteration delivery and release notes as necessary

- Display a high level of critical thinking in cross-functional process analysis and problem resolution for new and existing products.

- Develop & conduct specialized training on new products launched and raise awareness & application of relevant subject matter.

- Monitor internal processes for efficiency and validity pre & post product launch/changes.

Requirements:

- Excellent communication skills, both verbal and in writing.

- Strong customer focus paired with exceptional presentation skills.

- Skilled at data analytics focused on identifying opportunities, driving insights, and measuring value.

- Strong problem-solving skills.

- Ability to work effectively in a diverse team environment.

- Proven strategic and tactical leadership, motivation, and decision-making skills

Required Education & Experience:

- Bachelor's Degree in Technology related field.

- Experience in working with a geographically diverse development team.

- Strong technical background with the ability to understand and discuss technical concepts.

- Proven experience in Software Development and Product Management.

- 12+ years of experience leading product teams in a fast-paced business environment as Product Leader on Software Platform or SaaS solution.

- Proven ability to lead and influence cross-functional teams.

- Demonstrated success in delivering high-impact products.

Preferred Qualifications

- Transition from software development role to product management.

- Experience building messaging solutions or marketing or support solutions.

- Experience with agile development methodologies.

- Familiarity with design thinking principles.

- Knowledge of relevant technologies and industry trends.

- Strong project management skills.

1.   In-Depth knowledge and experience with C# .NET Core are must.

2.   Experience in working with API Gateways, REST, SOAP, OAuth, SAML.

3.   Experience inworking with Kafka based environment.

4.   Microservices and Event driven Architecture (with a focus on cloud).

5.   Experience and understanding of OOPS and SOLID design principals.

6.   Well verse with Design Patterns.

7.   Familiarity with Azure and AWS offerings.

8.   Understanding of Relational and NoSQL databases SQL Server, Azure SQL, MongoDB, Elastic.

9.   Familiarity with the .NET framework

10. Familiar with various design and architectural patterns

11. Knowledge of concurrency patterns in C#

12. A willingness to get trained and work on cutting edge technologies like React, Node etc.

13. Understanding fundamental design principles behind a scalable application

14. Implementing automated testing platforms and unit tests

15. Proficient understanding of code versioning tools Git

Familiarity with CICD tools, JIRA, Azure devops etc

Job profile- Oracle _ Solution Architect
Experience – 6+ years
Location- Bangalore/ Chennai/ Pune/ Noida
Salary- 30 LPA
Qualification- Any
Job Location- Bangalore/ Chennai/ Pune/ Noida
Key Skills- Oracle ERP cloud solutions, Rollout or implementation, Oracle EBS
Roles & Responsibilities-

• Solution architect experience in the delivery of Oracle ERP cloud solutions, leading the design and implementation of Oracle ERP Cloud Solutions across a range of client industries and leading customer engagements and advising on Oracle fusion related topics.
• Strong hands-on experience with Oracle Cloud ERP solution architectures, design, rollout and implementation leadership.
• 8 years minimum experience in Oracle EBS and Oracle ERP Cloud with the majority of recent experience in Oracle Fusion (Cloud) applications.
• Minimum 4-6 years of experience in Oracle cloud solution implementation. Recent experience in a lead role in at least 2 full ERP Cloud implementations

Desired Candidate Profile

• 5+ years of experience as a Database Developer or DBA or similar role
• Experience in SQL, No-SQL and Graph databases
• Experience in Microsoft SQL Azure
• Experience with Performance Tuning, optimization, backups, restores and recovery models
• Experience of High Availability (HA) and Disaster Recovery (DR) options for SQL Server
• Sense of ownership and pride in your performance and its impact on the company’s success
• Good time-management skills
• Great interpersonal and communication skills    

• Experience with Hibernate and Spring.
•   Experience with Springboot, spring MVC
• Experience with all phases of the Software Development Lifecycle, including system analysis, design, coding, testing, debugging and documentation
• Teamwork & collaboration skills to work across organizations
• Problem solving skills to develop quick yet sound solutions to resolve complex issues
• Programming Language(s): Java, J2EE, JSON, HTML, DHTML, HTML 5, XML, EXTJS.
• Experience with XML/HTTP and Web Services
• Experience with HTML, JSP, CSS, JQuery / Ajax / JSON,
•     Experience /Knowledge of Angular, React.
• Experience building J2EE based Web Applications
• Experience with MySql.