36 Iec 62304 Jobs

As a Product Manager at mlHealth 360 , you will lead the next phase of development for our AI-driven Radiology solutions, including medical imaging diagnostic AI products. The ideal candidate will combine technical acumen, clinical understanding, and regulatory awareness to drive end-to-end product lifecycle from concept to deployment and compliance with Indian SaMD regulations. Key Responsibilities 1. Product Strategy & Roadmap Define and own the product roadmap for AI-based radiology applications in CT, MRI, and X-ray domains. Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities. Collaborate with leadership to align product goals...

Technical Writer (Medical Devices) Intern Location: Chennai IIT Madras Research Park (Onsite) Employment: Contract (6 months) with option to extend or convert to full?time Start: Immediate Salary: 10,000 per month Why this role Floaid is finalizing documentation for a new platform. We need a hands?on technical writer who can rapidly bring our User/Operator Manual , Service & Maintenance Manual , Installation & Commissioning Guide , and related controlled documents to release quality under a medical?device QMS. What you'll own (deliverables) Operator Manual (IFU): setup, priming, alarms, operating modes, UI walkthroughs, cleaning/sterilization, warnings/contraindications, symbol glossary (ISO...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

Key Responsibilities: Develop and maintain a Software Verification Plan (SVP) per IEC 62304, ensuring coverage of all required activities (unit, integration, system, acceptance). Align verification activities with the organization's Quality Management System (QMS) as required by ISO 13485, ensuring all SOPs, templates, and records are used and maintained. Establish and maintain traceability between software requirements, risk controls, and verification tests. Oversee creation and peer review of verification protocols, test cases, test scripts, and test data, ensuring direct traceability to software/system requirements and risk mitigations. Ensure objective evidence (test records, logs, scree...

The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company's strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company's interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market. The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory require...

Role & responsibilities Lead firmware development activities across multiple medical device projects, ensuring high-quality, reliable, and efficient code implementation Design comprehensive firmware architecture that meets both performance and regulatory requirements Develop embedded software for medical devices primarily using the STM ecosystem (STM32 microcontrollers) Implement robust communication protocols and interfaces with other system components Lead the implementation of IEC 62304 standards within the firmware development process Create and maintain comprehensive documentation for regulatory submissions (Indian regulatory pathway and future FDA submissions) Develop validation and ve...

Role & responsibilities • ISTQB Certification • Experience on product testing • Experience in smoke, stress, exploratory Testing • Experience in verification for medical products • Hands-on software enterprise application development experience • Exposure to ALM tool, Python • Knowledge of medical device software development is highly preferred including knowledge of standards such as IEC 62304, ISO 14971

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management ca...

Requirements Minimum 3 years experience and successful track record in selling commercial software tools or embedded software solutions. A minimum of 50% travel is required within the territory. Graduate with relevant experience. MBA will be an added advantage. Working Experience in the design/manufacture of embedded software solutions and Safety standards (i. e., IEC 61508 IEC 62304 ISO 26262 DO-178C) is an advantage. Independent and motivated sales professional skilled in sales plan development and execution required for: - Hunter's sales role in defined geography and target accounts. Disciplined prospecting targeted at key decision makers in embedded systems divisions/groups. Ability to f...

About the Role: We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions. Key Responsibilities: Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based platforms, and AI components Apply knowledge of Sa...

Department : Product, Data and AI Engineering About the Role: We are seeking a highly skilled and detail-oriented Test Engineer with a strong background in medical technology (MedTech) and Artificial Intelligence (AI) to join our dynamic team. This role is critical in ensuring the safety, reliability, and compliance of AI-powered medical devices and Software as a Medical Device (SaMD) solutions. Key Responsibilities: Understand and evaluate the usage of AI/ML models in medical devices, including algorithm behavior, data integrity, and performance under various clinical scenarios. Design and execute comprehensive white-box and black-box testing strategies for embedded systems, cloud-based pla...

We are also Considering candidates Willing to Relocate - Job Location : Chennai Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Experience : 15 - 25 Years We are accepting Job Applications : Please submit updated CV - Email : [HIDDEN TEXT];[HIDDEN TEXT] Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, ...

Opportunity to work with a global medical equipment company Opportunity to take on a leadership role and contribute to the company's vision About Our Client Our client is a leading global medical technology company that provides innovative solutions in diagnostic and therapeutic imaging, laboratory diagnostics, and digital health services. Job Description The Successful Applicant Regulatory Strategy Development Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals. Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines. Lead initiatives to address regulatory challenges in emerging ...

This role is part of R&D (Research & Development) focusing on Software Verification & Validation (V&V) for healthcare/medical/pharma-related systems. Key Responsibilities Perform software verification & validation to ensure compliance with medical device/healthcare software standards. Develop, execute, and automate test cases, scripts, and frameworks. Work on test planning, defect tracking, debugging, and quality assurance activities. Collaborate with cross-functional teams R&D, product engineering, and regulatory teams. Ensure compliance with ISO 13485, IEC 62304, FDA guidelines (typical in medical software). Skills & Requirements Strong background in manual + automation testing for softwar...

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing proefficiency their laboratories, improving patient health through diagnostics or the developme...

Job Description : Work Schedule Standard (Mon-Fri) Environmental Conditions Office Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing proefficiency their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an unrivalled combination of innovative technologies, purc...

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. The RA/QA Engineer typically serves as the quality representative on the project team and works closely with the project team leader. Responsible for minimizing risk to the organization associated with product design and realization efforts and assists in ensuring robust medical device product designs under governing dome...

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking ...

System Engineer /Sr. Systems Engineer Location: Pune, India Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany) Industry: Medical Devices / Engineering Services Employment Type: Full-time Role Summary: We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and do...

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Job Description We are looking for a skilled & driven Product Owner with a strong technical background and experience in the healthcare domain. The ideal candidate will lead the product /platform development efforts, ensuring ...

We are also Considering candidates Willing to Relocate - Job Location : Chennai Experience : 15 - 25 Years We are accepting Job Applications : Please submit updated CV - Email : [HIDDEN TEXT];[HIDDEN TEXT] Embedded Firmware Architect | Medical Devices | IEC 62304, IEC 60601 | Senior / Firmware Architect - Medical Devices | 10 - 20 Years | Job Description Responsibilities include - Design and architect embedded software systems from concept to production. - Lead and mentor a team of embedded software engineers. - Develop and maintain embedded software architectures and design patterns. - Optimize software for performance, reliability, and power consumption. - Conduct code reviews and ensure c...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for...

Job Description Job Title : Sr Specialist -I Software Quality Engineer In this role, you have the opportunity to Ensures that appropriate SW Quality plans are made that include all stages ofu00A0the software life cycle and supports SW Quality Plan designu00A0 Validates key design inputs like: usability, reliability, performance,u00A0 u00A0supportability, manufacturability, localizability, safety, security, privacy, u00A0serviceability, sustainability and costsu00A0 Provides effective oversight of: the execution of the SW Quality Plan and any u00A0Risk Management activities, and of all design related activities during theu00A0software lifecycleu00A0 You are responsible for u00A0 To lead quali...