11+ ISO 13485 Jobs in Bangalore (Bengaluru) | ISO 13485 Job openings in Bangalore (Bengaluru)

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.

🛠️ Key Responsibilities

• Design, build, and maintain scalable data pipelines using Python and Apache Spark (PySpark or Scala APIs)
• Develop and optimize ETL processes for batch and real-time data ingestion
• Collaborate with data scientists, analysts, and DevOps teams to support data-driven solutions
• Ensure data quality, integrity, and governance across all stages of the data lifecycle
• Implement data validation, monitoring, and alerting mechanisms for production pipelines
• Work with cloud platforms (AWS, GCP, or Azure) and tools like Airflow, Kafka, and Delta Lake
• Participate in code reviews, performance tuning, and documentation

🎓 Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering, or related field
• 3–6 years of experience in data engineering with a focus on Python and Spark
• Experience with distributed computing and handling large-scale datasets (10TB+)
• Familiarity with data security, PII handling, and compliance standards is a plus

Responsibilities: 

● Work with principal stakeholders & decision makers in client organizations to understand their Business/Organization Goals, User/Customer Behavior, and create Design Roadmaps & Strategies for their Services & Products. 

● Collect & analyze Business Requirements, create Design briefs & proposals, convert sales inquiries into projects. 

● Lead prioritization discussions with leadership teams, defining scope, budget, timelines and resource allocation. 

● Lead the Design Studio & projects to on-time and quality delivery as agreed by the client. 

● Guide excellent design delivery, with thorough understanding of UX & UI Design. 

● Work closely with Frontend & backend development, Content & Communication, Digital Marketing and other teams to ensure the success of the projects. 

● Raise and negotiate issues and risks with senior management of the client. 

● Manage profitability of the projects & design studio. 

● He/she needs to guide team members well and facilitate their constant learning in the organization. 

● Stay up-to-date with latest achievements, best practices and trends in design. 

● Establish best practices and design-thinking processes across the organization. 

Expectations: 

● Minimum 10+ years of core UX & UI Design experience. 

● At least 3 years of experience leading and managing a small to medium design team (20 to 40 Members). 

● Should have led at least 12 product design client projects hand-on, involving UX & UI Design teams, Front end development teams. 

● Should have led & delivered at least 3 client projects in CX or Service Design. 

● Experience in UX & UI Design for web, mobile & TV.

● Should be willing to travel for short/long durations in India and abroad for work. 

● Thought Leader in Strategic UX Design. 

● Ability to decode complex technical content

• Drive the architecture and design of large-scale, multi-tiered, distributed software applications, tools, systems and services using object-oriented design, distributed programming, Java/Node/ Python, .Net.
• Hands on experience in delivering high quality software products.
• Gather business and functional requirements from external and/or internal customers and end-users, and translate requirements into technical specifications to build robust, scalable, supportable solutions that work well between a ranges of complex systems.
• Serve as technical lead throughout the full development lifecycle, end-to-end, from scoping, planning, conception, design, implementation and testing, to documentation, delivery and maintenance.
• Provide design reviews for other engineers, including feedback on architecture and design issues, as well as integration, performance and scalability.
• Manage resources on multiple technical projects and ensure schedules, milestones, and priorities are compatible with technology and business goals.

• Be the analytical expert in Kaleidofin, managing ambiguous problems by using data to execute sophisticated quantitative modeling and deliver actionable insights.
• Develop comprehensive skills including project management, business judgment, analytical problem solving and technical depth.
• Become an expert on data and trends, both internal and external to Kaleidofin.
• Communicate key state of the business metrics and develop dashboards to enable teams to understand business metrics independently.
• Collaborate with stakeholders across teams to drive data analysis for key business questions, communicate insights and drive the planning process with company executives.
• Automate scheduling and distribution of reports and support auditing and value realization.
• Partner with enterprise architects to define and ensure proposed.
• Business Intelligence solutions adhere to an enterprise reference architecture.
• Design robust data-centric solutions and architecture that incorporates technology and strong BI solutions to scale up and eliminate repetitive tasks.

• Experience leading development efforts through all phases of SDLC.
• 2+ years "hands-on" experience designing Analytics and Business Intelligence solutions.
• Experience with Quicksight, PowerBI, Tableau and Qlik is a plus.
• Hands on experience in SQL, data management, and scripting (preferably Python).
• Strong data visualisation design skills, data modeling and inference skills.
• Hands-on and experience in managing small teams.
• Financial services experience preferred, but not mandatory.
• Strong knowledge of architectural principles, tools, frameworks, and best practices.
• Excellent communication and presentation skills to communicate and collaborate with all levels of the organisation.
• Preferred candidates with less than 30 days notice period.

Oracle OAS Developer

Senior OAS/OAC (Oracle analytics) designer and developer having 3+ years of experience. Worked on new Oracle Analytics platform. Used latest features, custom plug ins and design new one using Java. Has good understanding about the various graphs data points and usage for appropriate financial data display. Worked on performance tuning and build complex data security requirements.

Qualifications

Bachelor university degree in Engineering/Computer Science.

Additional information

Have knowledge of Financial and HR dashboard

• Own our user interfaces with an eye to lightning-fast performance and a great user experience
• Implement compelling and intuitive UIs, shaping the design and feel of the product alongside our founders
• Write a significant amount of code for new and existing features
• Ship high-quality code and architecture
• Mentor engineers on the team, developing their skills and helping advance their careers
• Help shape the future of our engineering organization

Requirements

• You have been building production web applications for 5+ years and know the systems from top to bottom
• You know SQL and have significant programming experience on the frontend with React
• You have a BS/MS/Ph.D. in a scientific field or equivalent experience
• You want to work in a fast-paced, high-growth startup environment that respects its engineers and customers
• Comfortable working with a 100% distributed engineering team, collaborating on GitHub, Slack, Zoom, etc. in the open and as a self-starter.

Bonus points

• You have backend experience building microservices
• You’ve contributed to open-source libraries and actively participate in the development community (blogging, meetups, tweeting, etc.)
• You have experience building interactive data visualizations
• You have worked in TypeScript, Java, Go