18 Iec 62366 Jobs

Job Description Required Qualifications: Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ years of clinical experience. Minimum 10+ years experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). Strong understanding of clinical risk, safety analysis, and usability validation methodologies. Proven ability to translate complex clinical workflows into clear design and engineering requirements. Excellent cross-functional communication and documentation skills. Preferred: Experience sup...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Cepheid, one of Danaher's 15+ operating companies, our work saves livesand 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. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impac...

Job Title Reliability Engineer Job Description In this role, you have the opportunity to Be an integral part of the Sleep and Respiratory Care (SRC) R&D team, actively participating in Sleep and Respiratory Care product development. SRC team has a broad product portfolio of advanced life support solutions and data management solutions. Our mission is to design, produce, and deliver every solution as if the life of someone we love depends on it. Every day, we empower and enable our customers - from clinicians to paramedics, first responders to the everyman - to save lives using our innovative, market-leading technology. We are looking for a passionate Reliability Engineer to join us as we str...

Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages ...

Job Title Software Design Quality Engineer Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and qual...

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...

Key Responsibilities: Assure compliance with software procedures and guide teams on development life cycle appropriateness Identify task dependencies and ensure effective development and maintenance efforts Lead both internal and external audits for software quality systems Provide training on ASP software quality engineering procedures to staff, contractors, and business partners Lead compliance and risk management activities for software or system projects Improve software quality processes based on industry trends and regulatory expectations Ensure compliant, reliable systems prioritizing patient safety are transferred to users Manage software change control in alignment with quality proc...

Key Responsibilities: Assure compliance with software procedures and guide teams on development life cycle appropriateness Identify task dependencies and ensure effective development and maintenance efforts Lead both internal and external audits for software quality systems Provide training on ASP software quality engineering procedures to staff, contractors, and business partners Lead compliance and risk management activities for software or system projects Improve software quality processes based on industry trends and regulatory expectations Ensure compliant, reliable systems prioritizing patient safety are transferred to users Manage software change control in alignment with quality proc...

Job Description Help shape the future of healthcare by designing safe and intuitive image guided surgery and diagnostic imaging systems. As a Usability Designer, you will apply human factors and usability expertise to ensure Philips IGT products meet user needs and regulatory requirementsenabling clinicians to deliver faster, more effective care. Your role: Make a greater impact by improving the safety, usability, and effectiveness of our IGT systems, directly supporting better outcomes for patients and caregivers. Collaborate with cross-functional teamsincluding engineering, clinical, marketing, quality, regulatory, and serviceto deliver human-centered solutions that meet global medical dev...

Position Summary: We are looking for an experienced R&D Engineer Trainer with 1015+ years of expertise in the medical device industry . This role will focus on leading training programs in the design , development , and optimization of innovative medical technologies . The trainer will provide guidance on the full new product development (NPD) lifecycle from concept through commercialization while ensuring alignment with global regulatory requirements. The position also involves close cross-functional collaboration to support the delivery of safe, effective, and high-quality medical devices that enhance patient outcomes. Key Responsibilities: Lead the design and development of new medical de...

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launc...

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...

Understanding human capabilities and limitations (cognitive, physical, sensory). Applying ergonomic principles to device design to reduce user strain and error. Familiarity with FDA guidance on usability engineering and human factors. Understanding of IEC 62366-1 standards for usability in medical devices

Experience: 4-8 Years Location: Bangalore Usability Engineer, Usability Assessments, Medical product Usability. Formative evaluation, Summative Evaluations, Requirements Gathering, Documentation, user survey. Observation and Moderation, UFMEA, Task Analysis. Knowledge in IEC 62366, HE 75., Human Factor Engineering

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...

Role & responsibilities: The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. The candidate should be well versed with overall R&D, Quality, and Regulatory processes for medical devices. Lead HFID projects including development of study plans and feasibility. Participate and support in data collection Implement BSC global PLCP process with required SOPs suitable for regional / emerging market projects. Lead projects to integrate HFID into ongoing projects by considering customer insights (voice of customer, voice of business, voice of regulatory, voice of technology) Voice of Business - Work closely with regi...

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and form...

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publis...