L&T Technology Services · 1 day ago
Design Quality Engineer
L&T Technology Services is seeking a Design Quality Engineer to lead post-market design changes for capital hardware. The role involves evaluating product issues, updating documentation, and collaborating with various departments to manage design quality and risk effectively.
Responsibilities
Evaluate product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware
Update DFMEA and DHF documents as needed as part of the post market design change management process
Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management
Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase
Support Complaint trending and Severity trending signal dispositions
Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
Makes decisions and proposes solutions based on calculated risks identified through data analysis
Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines
Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities
Qualification
Required
Evaluate product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware
Update DFMEA and DHF documents as needed as part of the post market design change management process
Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management
Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase
Support Complaint trending and Severity trending signal dispositions
Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation
Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings
Makes decisions and proposes solutions based on calculated risks identified through data analysis
Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines
Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities
Benefits
Paid Leave
Health Insurance
Group life insurance
Disability
401(K)
Company
L&T Technology Services
L&T Technology Services is an engineering services company that offers digital, product, manufacturing, and plant engineering services.
H1B Sponsorship
L&T Technology Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (787)
2024 (809)
2023 (821)
2022 (880)
2021 (872)
2020 (1441)
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-09-23IPO
Leadership Team
Recent News
2026-01-16
Business Standard India
2026-01-16
2026-01-16
Company data provided by crunchbase