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8.0 - 12.0 years

2 - 3 Lacs

remote, india

On-site

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 devices, from feasibility studies through product launch. Oversee product development lifecycle including concept generation , prototyping , design verification & validation , risk analysis , and design transfer to manufacturing . Ensure compliance with FDA, ISO 13485, MDR, IEC 60601, ISO 14971 and other applicable regulations and standards. Drive innovation by identifying new technologies, materials, and processes that enhance product performance and cost-effectiveness. Lead technical design reviews, root cause analysis, and continuous improvement initiatives. Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Marketing to ensure successful product development and launch. Manage design documentation including Design History File (DHF), Design Inputs/Outputs , and Risk Management Files . Provide technical leadership and mentorship to junior engineers and project teams. Interface with clinicians, key opinion leaders (KOLs), and end-users to incorporate clinical feedback into design. Lead problem-solving initiatives for product performance, reliability, and usability. Stay updated with medical device industry trends, regulatory changes, and emerging technologies. Qualifications & Requirements: Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field . 10-15+ years of progressive experience in R&D within the medical device industry. Strong knowledge of medical device product development processes, including Design Control per 21 CFR Part 820. Proven track record of successfully launching medical devices into global markets. Expertise in CAD tools (SolidWorks/Creo/AutoCAD) , prototyping, and testing methods. Experience with risk management (ISO 14971), usability engineering (IEC 62366), and biocompatibility standards (ISO 10993) . Strong project management and leadership skills with experience in leading cross-functional teams. Excellent problem-solving, analytical, and communication skills. Experience with Class II and Class III medical devices preferred. Core Competencies: Innovation & Creativity in Medical Device Development Regulatory & Quality compliance mindset Leadership & Mentorship abilities Cross-functional Collaboration Strong Analytical and Technical problem-solving Strategic thinking with hands-on execution

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7.0 - 9.0 years

0 Lacs

kolkata, west bengal, india

Remote

Wondering what's within Beckman Coulter Diagnostics Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful. Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges. The Staff Technical Operations Scientist for Beckman Coulter Diagnostics is responsible for ensuring the successful establishment of Beckman Coulter products being manufactured in India by an OEM partner. The role will i nclude aspects of Quality Assurance, Design Transfer, Test Method Transfer and the setup and validation of equipment and manufacturing processes. This position is part of the located in and will be located at the OEM manufacturing site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time. You will be a part of the and report to the Senior Staff Technical Transfer Scientist who isresponsible for If you thrive in a multifunctional, fast paced & supporting role and want to work in a Technical Operations Team and be involved in product realization, read on. In this role, you will have the opportunity to: . . . . . . . . The essential requirements for the role include: Bachelor's degree with 9+ years experience OR Master's degree with 7+ years experience. Proven problem investigation and problem solving skills are essential. Demonstrated ability to effectively prioritize and lead a team to deliver on commitments and meet the needs of the business. Prior experience managing strategic Supply chain projects. A good working understanding of cGMP and ISO/FDA requirements. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit .

Posted 2 weeks ago

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