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.

Required Skills:

• Thorough knowledge on Sheet metal component design, material and thickness selection
• Competent on Electrical harness modeling in CATIA V5 – Electrical harness Routing (EHI) and Electrical Fitting installation.
• Independently handle Electrical harness modeling related to subsystem and car level..
• Able to interpret electrical schema and good understanding and able to apply while routing the harness
• Wire Bundle calculation
• Selection of protection, connectors, conduit, etc…
• Good Knowledge of materials  & mechanical characteristics
• Ability to perform a weight assessment on assemblies, aggregates and installations
• Ability to analyze manufacturing non-conformity and to validate a back-up solution.

Job Description:

Responsibilities:

• Identify relevant data sources - a combination of data sources to make it useful.
• Build the automation of the collection processes.
• Pre-processing of structured and unstructured data.
• Handle large amounts of information to create the input to analytical Models.
• Build predictive models and machine-learning algorithms Innovate Machine-Learning , Deep-Learning algorithms.
• Build Network graphs , NLP , Forecasting Models Building data pipelines for end-to-end solutions.
• Propose solutions and strategies to business challenges. Collaborate with product development teams and communicate with the Senior Leadership teams.
• Participate in Problem solving sessions

Requirements:

• Bachelor's degree in a highly quantitative field (e.g. Computer Science , Engineering , Physics , Math , Operations Research , etc) or equivalent experience.
• Extensive machine learning and algorithmic background with a deep level understanding of at least one of the following areas: supervised and unsupervised learning methods , reinforcement learning , deep learning , Bayesian inference , Network graphs , Natural Language Processing Analytical mind and business acumen
• Strong math skills (e.g. statistics , algebra)
• Problem-solving aptitude Excellent communication skills with ability to communicate technical information.
• Fluency with at least one data science/analytics programming language (e.g. Python , R , Julia).
• Start-up experience is a plus Ideally 5-8 years of advanced analytics experience in startups/marquee com

Required Skills:

Machine Learning, Deep Learning, Algorithms, Computer Science, Engineering, Operations Research, Math Skills, Communication Skills, SAAS Product, IT Services, Artificial Intelligence, ERP, Product Management, Automation, Analytical Models, Predictive Models, NLP, Forecasting Models, Product Development, Leadership, Problem Solving, Unsupervised Learning, Reinforcement Learning, Natural Language Processing, Algebra, Data Science, Programming Language, Python, Julia

Mandatory Skills: Exp in anyone MNC framework (Laravel/Codeigniter/CakePHP)

Roles and Responsibilities:

1. As a PHP Developer, you will be responsible for developing and coding all server-side logic using the CakePHP framework.
2. Writing back-end code and building efficient PHP modules.
3. Understand existing software products and contribute towards improving it.

JD –

Having experience in Implementing Integration Solutions using Oracle Integration Cloud Service.

Developed integration between SaaS application (Oracle Cloud ERP, Oracle Cloud HCM) and between SaaS and PaaS application

Should have worked extensively on minimum 3-4 Technology Adapters like File, Database, Oracle ERP & FTP adapter

Should have excellent skill in Web Service technologies such as XML, XPath, XSLT, SOAP, WSDL, and XSD

Experience in all phases of software development lifecycle from gathering requirements to documentation, testing, implementation and support Ability to troubleshoot technical and configuration issues

Should be able to communicate effectively with the functional & technical groups and various technical team members.

Ensure completion of tasks, milestones, and components including Technical specifications, design specifications, configurations, quality assurance, implementations, and project reviews

SEAMEDU- ACADEMIC ADVISOR

Company Name, Profile, Work Culture: Seamless Education and Services Pvt. Ltd (SEAS)

Seamedu - School of Pro Expressionism a full fledge media school producing world class talent in Media & Entertainment (M & E) fields of Film Making, Animation, Game Design & Development, Visual Effects, Sound Engineering, Photography, and Broadcast Journalism. Seamedu is an institution that nurtures the creativity of the students. Seamedu has been awarded by the Government of Maharashtra in IT & IT related Fields-Multi - media/ Entertainment/ Game. Seamedu also has campuses in Bangalore, Mumbai & Chandigarh. To know more about us, please visit – http://www.seamedu.com/">www.seamedu.com.

Job Description:

Business Development

1. Handling fresh enquiries via phone call, email, walk-ins and assisting with their educational goals.
2. Provide academic advising and guidance to prospective lead, students from the point of enquiry to enrolment.
3. Adhere to defined outreach timelines accurately and consistently; responding to student outreach within a 24-48 hour window.
4. Follow up calls/emails to the prospective students
5. Updating CRM effectively and adhering to admission process.
6. Achieve Admission goals for programs
7. Submit daily activity report to immediate superior
8. Provide presales input in terms of collecting target audience database, managing mailers/e-mailers campaign etc.
9. Analysis of earlier marketing data to support fresh marketing plans

Student Relations

1. Attendance Management
2. Student Relations & Grievance Handling
3. External Visits & Events Coordination

    Specific Skill Set :

• Professional experience in achieving admissions for academic program.
• Familiarity with higher education and online learning environments.
• Target oriented and focused
• Good communicator (both oral and written) in English and coordination skills
• Well versed with all tools of MS office
• Self-motivated, initiator and results-oriented
• Should demonstrate positive attitude, high motivation and interpersonal skills

Minimum/Maximum/ Work Experience Required: 1 to 5 years

Location(s) of Job: Pune

Minimum Education Requirements: Graduate in any stream with relevant experience

No of rounds of Interviews: 3

Work Timings : 9:30 am to 6:30 pm

Languages : English, Hindi

 Any other skill set:

• Enjoys working with people of all ages, from youth to parents and college staff
• Efficiently organized, with the ability to maintain detailed records
• Time management and follow-up skills

About the Company
Based in California’s Silicon Valley, WebShar is focused on enabling innovative teams to bring their ideas to life. WebShar provides software development consulting services to innovative companies around the world. Through years of cutting edge technical expertise, the WebShar team utilizes their extensive knowledge of modern software development methodologies to help companies create innovative software solutions.

About the Job Role

 Primary  

• Java, J2EE, Spring MVC
• Hibernate or other ORM
• Web technology and security, REST framework
• Any one UI technology and ready to learn a new one.
• Database knowledge (MySQL, Oracle, Postgres)
• Unit testing frameworks
• Version Control (Eg., Git)

Good To Have  

• Microservices architecture implementation using docker and kubernetes
• Web technologies like HTML, CSS and Javascript
• Python, Shell Scripting

• Identify and analyze user requirements
• Prioritize, assign and execute tasks throughout the software development life cycle
• Document development phases
• Design database architecture
• Develop Java EE applications
• Write well-designed, efficient code
• Review, test and debug team members’ code
• Schedule product releases with internal teams
• Ensure our applications are secure and up-to-date
• Stay up-to-date on emerging technologies

• 6 to 8 years of work experience as a Senior Java Developer or similar role
• Experience designing, building and testing Java EE applications
• In-depth knowledge of popular Java frameworks like Spring MVC
• Experience with Object-Oriented Design (OOD)
• Good delegation and time management skills
• Problem-solving abilities
• BSc in Computer Science, Engineering or relevant field

Job Title: ERPNext Developer 
Job Type: Full – Time
Location: Pune
Work Hours: 9: 00 AM to 6:00 PM
Min Salary: As per the Standard Market Rates

MAIN DUTIES/RESPONSIBILITIES:

PRIMARY RESPONSIBILITIES:
The candidate will be required to Design, Configure, Build, Test, Deploy and Maintain ERPNext and Frappe based applications:

• Gathering technical requirements for internal and external customers.
• Creation of documentation for software development and testing.
• Participation and use of Agile development methodologies
• Drive continuous improvement in development and operations best practices
• Ability to convey complex information in both written and oral form to technical and non-technical audiences

QUALIFICATIONS, EDUCATION, AND SKILLS:
Core qualifications:

• Excellent written and verbal communication skills
• Good interpersonal communication skills are needed in order to work successfully with prospects, customers, and cross-functional teams to meet development timelines
• Able to understand the complex business process and manage the project.
• Strong aptitude for learning new technologies and understanding how to utilize them in a customer-facing environment
• Hands-on experience in developing ERP applications from the ground up.
• Ability to follow standard engineering principles and practices
• Creative approach to problem-solving
• Working knowledge of object-oriented design and development skills.
• Commercial eCommerce portal development and maintenance is preferred. 
• 1-5 years of Experince is mandatory.

Technical qualifications:

• Experience in Frappe, ERPNext, JS, MySQL, Python & Frappe based web development. 
• Hands-on Product development over Frappe Framework, ERPNext
• Experience with workflows, access controls, page layouts, custom objects, custom record types, reports, and dashboards design and development
• Experience with Scrum/Agile development methodologies 
• OOP concepts and Backend Development Experience
• MySQL on MariaDB or equivalent
• Hands-on experience with hosting web application on Apache or NGINX
• Experience in UI/UX development for Web Applications is essential.
• Experience with one or more ERPNext Modules like Human Resources, CRM, Buying, Selling, Asset Management, Stock, Buying, Accounting, and Project.
• Senior position requires experience with multiple modules of ERPNext. 
• BS in computer science or technology equivalent preferred