3 Days Left: Senior Technical Lead

3 weeks ago


Bengaluru, Karnataka, India HCLTech Full time

Designation Senior Technical Lead No of Positions 5 Skill Primary Tools and Standards ERS -Standards - Medical-MDR Job Family Development Posting About HCLTech HCLTech is a global technology company spread across 60 countries delivering industry-leading capabilities centered around digital engineering cloud and AI powered by a broad portfolio of technology services and products We work with clients across all major verticals providing industry solutions for Financial Services Manufacturing Life Sciences and Healthcare Technology and Services Telecom and Media Retail and CPG and Public Services We re powered by our people a global diverse multi-generational talent - representing 161 nationalities whose unique spark perspective and boundless passion drive our culture of proactive value creation and problem-solving Our purpose is to bring together the best of technology and our people to supercharge progress for everyone everywhere our clients partners their stakeholders communities and the planet As a company we are deeply focused on accelerating our ESG agenda We are also creating technology-enabled sustainable solutions with and for our clients and partners We embed ESG imperatives into every aspect of our business and ensure that the progress we supercharge is responsible inclusive and beneficial to all our stakeholders in the long term We have committed to achieving net zero by 2040 To learn more about how we can supercharge progress for you visit Senior Technical Lead with mdr ISO 13485 mdd Job Summary As a Senior Technical Lead specializing in mdr ISO 13485 and mdd the primary responsibilities include overseeing the technical aspects of projects related to medical device regulations and standards compliance The role involves ensuring adherence to ISO 13485 quality management systems and the Medical Device Directive MDD 1 Key Responsibilities 1 Lead technical teams in the implementation and maintenance of systems compliant with iso 13485 and mdd requirements 2 Provide expertise on mdr regulations and guidelines to ensure product development and validation processes meet the necessary standards 3 Collaborate with cross functional teams to align technical strategies with regulatory requirements 4 Conduct audits and assessments to verify compliance with mdr iso 13485 and mdd requirements 5 Develop and implement strategies to address technical challenges and optimize processes in compliance with medical device regulations Skill Requirements 1 Proficiency in interpreting and applying mdr regulations iso 13485 standards and the medical device directive mdd 2 Strong technical leadership skills to guide teams in achieving compliance goals effectively 3 Excellent communication skills to interact with stakeholders and convey technical requirements clearly 4 Analytical thinking to assess complex technical issues and develop appropriate solutions 5 Detail oriented approach to ensure accuracy and precision in compliance related tasks Certification in Medical Device Regulations MDR or ISO 13485 is a plus Skill Level 3 Secondary Skill 1 Technical Skills ERS -Other Technical Skills-Analog Circuit Design Skill Level 3 Secondary Skill 2 Tools and Standards ERS -Standards - Medical-ISO 13485 Skill Level 3 Secondary Skill 3 Technical Skills ERS -Product System-EMI EMC Design Skill Level 3 Secondary Skill 4 Domain Competencies ERS -Medical Devices-Regulatory-MDD



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