DHF Remediation Engineer

7 days ago

Pune, Maharashtra, India Cyient Full time ₹ 9,00,000 - ₹ 12,00,000 per year
  • Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions.
  • Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485.
  • Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files.
  • Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating effective communication among stakeholders.
  • Stay updated on current regulatory requirements and industry best practices related to medical device documentation and design controls, providing training and guidance to team members on DHF requirements and remediation processes.
  • Support risk management processes by integrating relevant risk analysis and mitigation strategies into DHF documentation, collaborating on development and updates to the product Risk Management File.
  • Utilize analytical skills to identify root causes of DHF issues and implement robust solutions, developing creative strategies to address complex documentation challenges.
  • Lead DHF remediation projects, ensuring timely completion of tasks and adherence to project timelines, and reporting project status, challenges, and achievements to management and stakeholders.
  • Conduct thorough reviews and validation of DHF and associated documentation to ensure compliance with quality standards, supporting audits and inspections by regulatory bodies with organized and accurate DHF documentation.
  • 2-6 years of experience in DHF preparation or remediation in the medical device industry, and demonstrate strong understanding of regulatory standards and requirements, excellent organizational, project management, and communication skills.

  • DHF Remediation Engineer

    2 weeks ago

    Pune, Maharashtra, India UST Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Bachelor's degree in Engineering, Biomedical, or related field5+ years of experience in DHF remediation or medical device documentationStrong understanding of FDA QSR, ISO 13485, and EU MDR requirementsExperience with risk management (ISO 14971), design controls, and product lifecycle documentationProficiency in document management systems and quality...

  • DHF Remediation Engineer

    2 weeks ago

    Pune, Maharashtra, India, Maharashtra UST Full time

    Bachelor’s degree in Engineering, Biomedical, or related field5+ years of experience in DHF remediation or medical device documentationStrong understanding of FDA QSR, ISO 13485, and EU MDR requirementsExperience with risk management (ISO 14971), design controls, and product lifecycle documentationProficiency in document management systems and quality...

  • Design Engineer

    1 week ago

    Pune, Maharashtra, India Infosys Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Design Engineer - Medical DeviceCAD - Solidworks & GDnT knowledge "• Bachelor's or Master's degree in Mechanical Engineering • Hands-on experience with medical device design control • Experience in mechanical product design and development • Proficiency in design change management, design documentation, risk management, and DFMEA • Familiarity with...

  • Design Engineer

    2 weeks ago

    Pune, Maharashtra, India Infosys Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Key Responsibilities:Bachelor s or Master s degree in Mechanical EngineeringHands on experience with medical device design controlExperience in mechanical product design and developmentProficiency in design change management design documentation risk management and DFMEAFamiliarity with Windchill or equivalent PLM toolExperience in DHF DMR...

  • Hiring For Design engineer_medical device-Pune

    1 week ago

    Pune, Maharashtra, India Glauben Technologies Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Role & responsibilities"• Bachelor's or Master's degree in Mechanical Engineering • Hands-on experience with medical device design control • Experience in mechanical product design and development • Proficiency in design change management, design documentation, risk management, and DFMEA • Familiarity with Windchill or equivalent PLM tool. •...

  • Risk Remediation Engineer – Unix

    7 days ago

    Pune, Maharashtra, India UBS Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    IndiaInformation Technology (IT)Group FunctionsJob Reference #313002BRCityPuneJob TypeFull TimeYour roleAre you a Risk Expert? We're looking for an engineer you is a Risk Manager and expert with remediating Risk:If you are a seasoned operating system engineer who is looking for challenging career prospects, then apply and ignite your career by joining UBS....

  • Design Engineer

    2 weeks ago

    Pune, Maharashtra, India Infosys Full time US$ 90,000 - US$ 1,20,000 per year

    Role & responsibilities:Product development experience in range of 4-7 yearsExperience with Medical device preferred.Experience with design change management and DHF deliverables.Good at communicationBasic understanding of PLM/WindchillTechnical report writing and communication with stakeholders.Skill Set:Must have -Product development experienceStrong DHF...

  • System engineer

    7 days ago

    Pune, Maharashtra, India Tata Elxsi Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Tata Elxsi is among the world's leading providers of design and technology services across industries, including Automotive, Broadcast, Communications, and Healthcare. Tata Elxsi is helping customers reimagine their products and services through design thinking and the application of digital technologies such as IoT (Internet of Things), Cloud, Mobility,...

  • Engineer II, Design Job Details

    7 days ago

    Pune, Maharashtra, India BOSTON SCIENTIFIC Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Job Description Engineer II, Design Work mode: HybridOnsite Location(s): Pune, MH, INAdditional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees, tackling...

  • Quality Engineer

    3 days ago

    Pune, Maharashtra, India Mega Epc Projects Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Looking for candidates with Welding Process knowledge,Code and STD -ASME,NDT Process Information,Weld defect and remediesand Process equipment knowledgeInterview location: Mega Engineering, P-52, Jadhavwadi, navlakh Umbre, MIDC ,Talegaon, PuneHealth insuranceAnnual bonusProvident fund