60 Iec 62304 Jobs

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 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. 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 im...

Role: R&D Manager - Systems Verification Location: Kharadi, Pune Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living. Join our dynamic Robotics Systems Test team where cutting-edge technology meets rigorous verification. As a Systems Verification Manager, you will lead a team in ensuring the safety, performance, and compliance of advanced robotic medical devices that integrate hardware, software, firmware, and cloud services. What will you doing Lead, mentor, and manage a team of Systems Verification Engineers, fostering a culture of technical excellence, accountability, and continuous improvement. Define team structure, roles, responsibilit...

About Intertek JOB DESCRIPTION Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely. True to the spirit of our founders, we lead the industry with unparallel ATIC services. The spirit ignited by our co-founder Thomas Alva Edison who gave one of the biggest inventions to the world ...

Responsibilities: 1. Conduct Product functionality analysis based on product requirements of embedded and electromechanical systems. 2. Executes, performs, summarizes, reports out verification & validation test activities of component / Sub-system / module. 3. Responsible for independently Verifying and Validating the device with minimal / no supervision 4. Good Team player and willing to take more proactive approach since beginning of brainstorming till execution. 5. Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources 6. Document Test Plans, Test Procedures based on functional and usability requ...

About Alcon At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. Position Summary Alcon is seeking a Senior Manager, Software Development to lead a small team of software engineers while actively contributing as a hands-on developer. This is a working manager rolebalancing leadership r...

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology At Radiometer, one of 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. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here...

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 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. 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 impact on a ...

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 impact on a global scale,...

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 Software Design Quality engineer to support CST ET products. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Hands on experience with tools package release process for both Software...

Job Description: The Enterprise Architect for Medical Device Software is a senior individual contributor responsible for defining and governing the software architecture and compliance framework for regulated medical devices. This role bridges product development, regulatory, and enterprise architecture functions - ensuring that device software solutions are designed securely, maintain regulatory compliance, and align with enterprise standards and long-term technology strategy. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, and s...

This job is with Danaher, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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...

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 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. 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 impact on a global sca...

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 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. 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 im...

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 impact on a global scale,...

At Cepheid our Bengaluru R&D Center is the global engine driving the future of diagnostics. We are an organization of innovators dedicated to creating sophisticated, life-saving technologies that provide faster, more reliable clinical insights. We are looking for a world-class executive to lead our integrated hardware and systems engineering organization and play a pivotal role in shaping the next generation of diagnostic platforms that will impact millions of lives. We are seeking a visionary and highly accomplished Director of Hardware & Systems Engineering to provide strategic and operational leadership for the entire physical product engineering organization. This executive role is respo...

Responsibilities Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations.? Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation.? Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements.? Devel...

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...

Summary: We are seeking a talented and detail-oriented Industrial Product Designer to join our innovative healthcare technology team. In this role, you will play a pivotal part in shaping the future of medical device design by creating user-centered, ergonomic, and aesthetically refined products that enhance patient care and clinical efficiency. Your work will directly impact the usability, safety, and manufacturability of critical healthcare solutions, from diagnostic tools to wearable devices. As an Industrial Product Designer, you will collaborate closely with cross-functional teams including engineering, regulatory, and clinical specialists to bring concepts from initial sketch to final ...

This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. ...

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...

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight ...

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 Design Quality engineer to support tool package role for CST-ET projects Responsibilities may include the following and other duties may be assigned Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with FDA ...

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 Responsibilities may include the following and other duties may be assigned Product Security Implement security requirements across the medical device development lifecycle by collaborating with teams to uphold best practices from design to deployment. Risk Assessment Conduct threat modeling and vulnerability assessments to identify and mitigate security risks throughout the product lifecycle. Security Monitoring and Vulnerability Asse...

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...