2 Ivd Regulations Jobs

At Cepheid, we are dedicated to enhancing healthcare by providing rapid and precise diagnostic testing solutions. Our relentless mission inspires us every day as we strive to develop innovative and scalable technologies to address the most challenging health issues worldwide. Join our team and be part of the journey to revolutionize molecular diagnostics from concept to delivery, ultimately improving patient outcomes in various healthcare settings. Working with us offers you the opportunity to make a significant global impact in an environment that nurtures professional growth and advancement. As a Process Engineer, your primary responsibility is to develop and implement strategies to enhance continuous process performance in terms of Safety, Quality, Delivery, and Cost within a manufacturing process or production line. You will drive continuous improvement initiatives, oversee equipment and process performance, conduct validations, and troubleshoot issues to optimize throughput capacity by mitigating constraints. Collaboration with global teams is essential in this role, as you will serve as the technical liaison to engineering and manufacturing teams in the US, Sweden, and India during the equipment/process lifecycle. Key Responsibilities: - Lead the planning and execution of installation and validation processes for new or existing equipment and products in compliance with company standards, IVD regulations, and GMP standards. - Prepare and maintain documentation in adherence to QMS requirements, including validation plans, SOPs, protocols, and reports. - Utilize continuous improvement tools to enhance production efficiency, reduce maintenance downtime, minimize inventory levels, and implement cost-saving initiatives. - Analyze test data to establish process or material specifications. - Conduct training sessions for Manufacturing personnel and peers on equipment processes, validations, quality requirements, and upgrades. Qualifications: - Bachelor's or Master's degree in biotechnology, electrical engineering, electronics, or related fields with a minimum of 3 years of manufacturing experience, preferably in the Medical Device/IVD sectors. - Proficiency in equipment and product validation for medical device manufacturing, including knowledge of mechanical design principles and machinery operations. - Experience working in a regulated environment (ISO, GMP, Medical Device regulations). Desired Qualifications: - Previous experience in a global work environment. - Excellent communication skills (written and oral) in English. - Strong analytical, problem-solving abilities, and technical acumen. - Familiarity with Lean manufacturing and Six Sigma methodologies. Join our dynamic team today and be part of a collective effort to accelerate the real-world impact of tomorrow's scientific and technological advancements. At Danaher, we celebrate diversity and recognize the value of unique perspectives that our associates, customers, and shareholders bring to our organization and the global markets we serve. Visit www.danaher.com for more information.,

You are passionate about improving health care through fast, accurate diagnostic testing. Your mission at Cepheid drives you every moment of every day as you develop scalable solutions to solve complex health challenges across the world. You are involved in every stage of molecular diagnostics, from ideation to the delivery of testing advancements that enhance patient outcomes. As a member of the team at Cepheid, you have the opportunity to make an immediate impact on a global scale in an environment that promotes career growth and development. Cepheid collaborates with six fellow Danaher Diagnostics companies to address the world's major health challenges by developing diagnostic tools that work at the pace of change, recognizing that behind every test, there is a patient waiting for results. As a Process Engineer at Cepheid located in Mahadeva Kodigehalli, Bangalore, Karnataka, you will be responsible for developing and executing a plan to improve continuous process performance related to Safety, Quality, Delivery, and Cost in a manufacturing process or line. Your role involves working on continuous improvement initiatives, ensuring overall equipment/process performance, executing equipment/process validations, tracking efficiency, and problem-solving. You will also leverage your process knowledge to identify opportunities to improve throughput capacity by reducing constraints. In this position, you will be the primary lead for defining and executing installation and validation processes for new or existing equipment and products, ensuring compliance with company standards, IVD regulations, and GMP standards. You will also plan and execute documentation as per QMS requirements, apply continuous improvement tools to increase production uptime, minimize maintenance, reduce inventories, and implement cost reduction initiatives. Additionally, you will plan, compile, and evaluate test data to determine appropriate limits and variables for process or material specifications and provide training to Manufacturing personnel and peers. To qualify for this role, you should have a Bachelor's or Master's degree in biotechnology, electrical, electronics, or related engineering fields with a minimum of 3 years of experience in manufacturing, preferably in the Medical Device/IVD sectors. You should have a strong background in equipment and product validation for medical device manufacturing, understanding of mechanical design concepts, and experience working in regulated environments such as ISO, GMP, and Medical Device regulations. Previous experience in a global environment, strong communication skills, analytical abilities, problem-solving skills, and familiarity with Lean manufacturing and Six Sigma would be advantageous. Join the winning team at Cepheid today and accelerate the real-life impact of tomorrow's science and technology. Partner with customers globally to architect solutions that bring the power of science to life. For more information, visit www.danaher.com. At Danaher, diversity is valued, and the unique perspectives contributed by associates, customers, and shareholders are recognized and embraced.,