36 Iec 62304 Jobs - Page 2

Job Description Core Skills 15+ years of hands-on software development experience, with 3-5 years in a senior/principal architect role. Proven expertise in C# .NET and/or Java. Flexibility to work across both technologies is strongly preferred. Solid experience in backend architecture including system design patterns, cloud infrastructure, scalability, and reliability. Proficient in cloud-native architectures using AWS (preferred). Experience with Azure or GCP is a plus. Strong foundation in software design principles, design patterns, and clean architecture. Demonstrated experience designing and implementing complex, multi-generation software products. Deep understanding of Healthcare softw...

Responsibilities: * Manage QMS implementation & maintenance * Conduct process audits & ISO audits * Develop & implement quality strategies * Collaborate with cross-functional teams on improvement initiatives

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowle...

Job Description The Software Quality Engineer is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development lifecycle across Abbott. Responsible for maintaining a strong collaborative partnership with cross-site and cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. About the team: The Software Quality Engineering team provides a fast-paced, dynamic work environment where engineers work closely with cross functional teams to provide software services to p...

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 ...

Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management. Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables. Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts. Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR. Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product la...

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...

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS appli...

We are seeking a skilled Software Test Engineer with experience in the medical device industry to join our dynamic team. The candidate will collaborate closely with cross-functional teams, including clinical, product, software, firmware, and hardware teams, to ensure product quality and compliance with industry standards. This role involves defining test strategies, creating test plans, executing test cases, and implementing automation solutions. Requirements and Qualifications: Bachelor's degree in Computer Science or related field 4 years of hands-on experience in software testing 2 years of experience in the regulated medical device industry Hands-on experience with cloud-based SaaS appli...

Immediate joiners with 9 - 15 years experience in Embedded C , Linux to design, develop, validate embedded software for healthcare and medical electronics systems, ensuring compliance with medical software development standards (IEC 62304). Required Candidate profile Strong hands-on experience in Embedded C Proficiency in Linux device driver development Domain knowledge in medical devices Exposure to IEC 62304 medical software standards (basic/limited)