11+ ISO 13485 Jobs in India

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.

Quality Engineer - Manual & Automation

Bengaluru (Hybrid)

Exp: 4 - 7yrs

About the Role

We're seeking a Quality Engineer to join our Product Integration team. You will play a critical role in ensuring software quality across our platforms by combining manual testing expertise with advanced automation capabilities.

What You'll Do

Technology & Delivery

• Understand application requirements and design features to develop comprehensive test cases

• Perform manual testing including ad-hoc, functional, UI, system, regression, and security testing

• Execute automation testing using Protractor, JavaScript, Selenium, and conduct API automation testing

• Execute full SQA cycle for software releases in fast-paced environments, including specification gathering, test plan development, test execution, and result analysis

• Participate in all verification aspects: requirements gathering, feature and functional testing, regression, load and performance testing

• Develop test cases for both Web and Mobile Applications

• Design test cases and execute tests using Microsoft Test Manager with comprehensive reporting

• Collaborate with leads and colleagues to define testing processes and strategies

• Clarify feature requirements to eliminate ambiguity

• Take ownership of all tasks related to assigned features

What We're Looking For

Work Experience

• 4-7 years of overall experience with manual and automation testing

• Working experience with Microsoft technologies, TFS, VSTS, and Microsoft Test Manager

• Relevant certifications in testing (a definite plus)

Technical Skills & Expertise

• Must have expertise in manual testing (ad-hoc, functional, UI, system, regression, security)

• Must have experience in automation testing using Protractor, JavaScript, and Selenium

• Must have experience in API automation testing

• Must have experience with Microsoft technologies, VSTS, and Microsoft Test Manager

• Strong knowledge of software development processes, particularly in Agile contexts

• Nice to have: Experience with Azure Cloud, DevOps, and CI/CD pipelines

Interpersonal & Digital Fluency

• Passion for technology, challenges, and quality with a dynamic, forward leaning, and proactive personality

• Excellent interpersonal skills to drive meaningful collaboration with strong team orientation

• Strong commitment to ownership, responsibility, and business/team objectives

• Ability to think creatively and innovatively in both technical and non-technical areas

• Excellent responsiveness with strong reporting and presentation skills

• Proficient English communication, both written and verbal

• Ability to inspire and motivate teams with assertiveness balanced with congeniality

• Active experience with modern team collaboration tools like Slack and Microsoft Teams

• Ability to create quality documentation (wikis, articles, blogs) and desirable presence in technology and architecture communities

Job Summary

We are seeking an experienced React Native Developer with hands-on expertise in developing and optimizing tvOS applications. The ideal candidate will have strong technical skills in React Native, a deep understanding of mobile app architecture, and prior experience with tvOS and focus navigation on Apple TV.

Key Responsibilities

• Develop and maintain React Native applications for iOS and Android platforms.
• Leverage native APIs for deep integrations across both platforms.
• Diagnose and fix bugs and performance bottlenecks for a native-like experience.
• Engage with the open-source community to encourage and contribute to key software fixes and improvements.
• Write and maintain clean, well-documented, and testable code.
• Create and execute automated tests to ensure product quality.
• Transition existing React web applications to React Native.
• Implement pixel-perfect UI designs and smooth animations for enhanced user experience.
• Integrate third-party APIs and SDKs.
• Ensure consistent UX across Android, iOS, and tvOS platforms.
• Release and manage applications on the Apple App Store and Google Play Store.
• Write performant applications optimized for low-end devices.
• Utilize debugging and development tools such as React DevTools and Charles Proxy.

Required Skills & Qualifications

• 5+ years of experience developing React Native applications.
• Strong proficiency in JavaScript, TypeScript, or ClojureScript (ES6+ syntax).
• Solid understanding of object-oriented programming principles.
• Ability to write clean, maintainable, and well-documented code.
• Expertise in managing third-party dependencies and resolving dependency conflicts.
• Experience with native build tools such as Xcode and Gradle.
• Good understanding of REST APIs, document request models, and offline storage mechanisms.
• Familiarity with automated testing suites and CI/CD pipelines.
• Strong skills in architecting and building React Native applications with clean architecture.
• Experience maintaining UX consistency across multiple platforms.

Preferred / Nice-to-Have Skills

• Experience with react-native-tvos and focus-navigation for Apple TV / tvOS.
• Knowledge of AVPlayer (iOS) and ExoPlayer (Android).

Designation: Financial Manager 

• Exp: 8-10 Years
• CTC: up tp 30 LPA

Regulatory, Contractual & US Healthcare compliances:

• Ensure compliance to HIPAA & Hi-Tech requirements framework through audits, policy updates, external certifications, internal awareness, etc.
• Periodically update policies and document new procedures / guidelines to update the compliance plan in line with operating changes.
• Work with legal & training teams to drive the compliance programs for awareness and update of important US healthcare regulations as applicable to business.
• Work with VP, Finance, HR & Legal team across all locations to consolidate & present the compliance to regulatory requirements periodically to LT and Audit Committee.
• Update the customer contractual checklists and monitor compliance to same through periodic reviews
• Train the team on compliance programs to deliver standard compliance experience across the locations.
• Enterprise risk management (ERM), Management reviews, Investigations & Internal Audits

Cab Boundary line- 

• Navi Mumbai to Ghatkopar
• Navi Mumbai to Panvel (Ulwe not covered)
• Navi Mumbai to Kalyan

Team Leadership: Recruit, train, and supervise staff, fostering a motivated and efficient team.

Sales & Profitability: Develop strategies to meet sales targets and enhance store profitability. resources.workable.com

Inventory Management: Oversee stock levels, order merchandise, and ensure efficient inventory control. manatal.com

Customer Service Excellence: Address customer inquiries and complaints, ensuring a high standard of service.

Operational Oversight: Ensure compliance with health and safety regulations and maintain store presentation.

Primary Skills: Database Systems (SQL), Python Flask/Fast API/Django frameworks specifically
Requirements:

• Highly proficient in fundamentals of Python web development frameworks like Flask, Django and Fast API
• Demonstrated experience in developing APIs using Python frameworks
• Should have deep knowledge in PostgreSQL, MS SQL Server and other SQL based Databases
• Knowledge and proficiency in NoSQL is a bonus

Attention all Graphic Designing Enthusiasts!

Kenaxs IT Private Limited is hiring a Graphic Designer in Vadodara. No matter your experience level, if you know how to use Corel Draw, AI, and Photoshop and are willing to work in agency culture, we want you! Also open to learn new designing softwares.

Salary ranges from 15-25k and immediate joining (0-15 days) is available.

Position Description

Title: Senior Service Engineer – North Region, India.

Reports to: P. Balasubramanian- National Manager – Services & Parts - India & South Asia

This role (Sr. Service Engineer) provides after sales support to north and east region customers located in Delhi/Punjab/Rajasthan/West Bengal and other north east cities.

In addition to annual initiatives, the key accountabilities of this position are:

1. MAIN JOB ACCOUNTABILITY

• Commissioning of Pumps and Controls in western region

• To work closely with Regional sales team and provide efficient after sales support

1. 2^ND MAIN JOB ACCOUNTABILITY

• Provide timely warranty service support to all customers in the region

• Co ordinate with factory Quality team and give feed back about field failures

1. 3^RD MAIN JOB ACCOUNTABILITY

• To achieve Service delivery targets given for the financial year.

• Work closely with all regional Reps to plan & achieve the service delivery objectives & Goals.

1. 4^TH MAIN ACCOUNTABILITY

• Participate in all the training programs conducted in factory and through online portal

• Train all regional rep engineers for all products and latest upgrades periodically

1. 5^TH MAIN ACCOUNTABILITY

• Co ordinate with all regional OEM’s engineers like Danfoss/HM/Tornatech/Clarke/Carel/Honeywell etc. to get timely service support

• Provide feedback on field failures to all OEM team members for corrective action.

• University Degree or Diploma in Mechanical/Electrical & Electronics Engineering

• 5– 7 years of Field service hands on experience working in HVAC/Pump/Building Automation industries

• Demonstrated knowledge of Pumps and Controls in HVAC & Fire applications

• Should have hands on experience in Electronics control panels in HVAC/Building Automation industries.

• Creative problem-solving skills, conflict management within different organizations (centralized and matrix organizational structures)

• Ability to break down complex problems in a simplified way, conduct root cause analysis and provide clear, well thought-out recommendations.

• Strong, team-oriented leadership skills with presence and a bias for action.

• Self-directed with ability to work autonomously and collaboratively and a focus on results.

• Ability to communicate in an open and authentic manner in all situations

• Identifying business opportunities by hunting, qualifying prospects, and evaluating their position in the industry.
• Actively reaching out to leads over various channels and converting them for sales
• You must be skilled at generating your own leads through various channels, networking, and driving your territory.
• Developing relationships with prospects and recommending company "real money gaming" products and solution through a consultative approach
• Capable of generating leads via various sources building a solid pipeline, doing thorough research around possible suspects, and qualify them.
• Create processes to optimize or automate the current processes and acting as a mentor to the new joiners in the team
• Helping prospects make an informed decision by providing support, information, and guidance upon developing a thorough understanding of the company products and overall industry
• Contribute to the overall strategy and initiatives taken up by the B2B vertical
• Identifying product improvements or new opportunities based on industry trends, market activities, and competitors
• Handling multiple clients concurrently and keep a track of all client transactions
• Contributing to team effort by accomplishing related results by adhering to delivery deadlines - Working cross-functionally to positively collaborate with colleagues
• Liaising and communicating client needs/requirements with senior management
• Forecasting, tracking sales metrics, and preparing sales plans
• Document every minute detail from inception to completion

• Prior B2B sales/ business development etc. experience
• Excellent communication skills- written & verbal both (English is a must)
• Good analytical skills & business sense
• Able to create varied business propositions, pitches according to the audience