| Job Title | Design Engineer |
|---|---|
| Category | Engineering |
| Location | Pune |
| Company | Larsen & Toubro (L&T) |
| Description | Role Overview The Mechanical Design Engineer R&D Documentation role is responsible for supporting new product development and sustaining engineering activities through the creation, remediation, and maintenance of compliant R&D and design control documentation. The role has a strong focus on risk management (FMEA), design history file (DHF) remediation, and regulatorycompliant technical documentation, working closely with Design Quality, Regulatory, and crossfunctional engineering teams. Mandatory Skills Strong working knowledge of: Design FMEA (DFMEA) and risk management lifecycle Design Controls and DHF structure Mechanical design fundamentals Familiarity with: ISO 13485 Quality Management Systems ISO 14971 – Medical device risk management FDA Design Control expectations (21 CFR 820 / QMSR) Key Responsibilities R&D Documentation & Design Controls Create, remediate, and update R&D documentation in alignment with global medical device regulations and standards. Author and maintain design control deliverables, including: Design Inputs and Design Outputs Design & Development Plans Design Review documentation Traceability matrices Support Design History File (DHF) creation, remediation, and audit readiness for legacy and new products. Risk Management & FMEA Develop, update, and remediate risk management documentation, including: Design FMEA (DFMEA) Use FMEA (uFMEA) Hazard Analysis Ensure risk files are compliant with ISO 14971 and aligned with intended use and essential safety requirements. Participate in and facilitate crossfunctional FMEA sessions to identify, assess, and mitigate product risks. Maintain risk traceability to design inputs, verification, validation, and labeling. Design Support & Engineering Collaboration Support mechanical design teams by translating design concepts into traceable, compliant documentation. Collaborate with: Design Quality Assurance Regulatory Affairs Manufacturing Engineering Systems and Software teams (as applicable) Support design change activities, sustaining engineering, and postmarket updates from a documentation and risk standpoint. Verification & Validation Documentation Support Support documentation for design verification and validation activities, including: Test plans and protocols Traceability to design and risk requirements Review of test reports for documentation adequacy Ensure design verification and validation documentation supports regulatory submission and audit requirements. Compliance & Audit Support Ensure all R&D documentation meets FDA QMSR, ISO 13485, and EU MDR expectations. Support internal and external audits by providing documentation evidence and addressing audit observations related to R&D and risk documentation. Participate in CAPA activities related to design and risk documentation gaps. Required Qualifications Education Bachelor’s or Master’s degree in Mechanical Engineering or related engineering discipline Experience 5–10 years of experience in medical device R&D, mechanical design engineering, or design documentation roles Handson experience working with Design Control and Risk Management documentation Experience supporting Class II and/or Class III medical devices preferred Technical & Regulatory Skills Mandatory Skills Strong working knowledge of: Design FMEA (DFMEA) and risk management lifecycle Design Controls and DHF structure Mechanical design fundamentals Familiarity with: ISO 13485 – Quality Management Systems ISO 14971 – Medical device risk management FDA Design Control expectations (21 CFR 820 / QMSR) Preferred Skills Experience with EU MDR design and risk documentation Exposure to: Design verification and validation documentation Usability risk considerations (IEC 62366 exposure is a plus) Experience using document management systems (PLM, eQMS, or equivalent) Soft Skills & Behavioral Competencies Strong documentation and technical writing ability High attention to detail and traceability Analytical and riskbased thinking mindset Ability to work effectively in crossfunctional and regulated environments Good communication skills to articulate design and risk rationale NicetoHave / ValueAdd Experience in DHF remediation projects for audits or regulatory submissions Prior involvement in regulatory inspections or notified body audits Six Sigma / Quality training exposure Experience working with global product development teams Why This Role Highimpact role supporting regulatory compliance and product safety Opportunity to work on complex medical devices and legacy remediation programs Exposure to global regulatory frameworks and audit environments Strong collaboration with quality, regulatory, and product engineering leaders |
| Salary | Not Disclosed |
| Last Date | 2026-07-17 00:00:00 |
| Apply Link | Click Here |
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