Role & responsibilities

- Execute design control processes in compliance with quality and regulatory requirements.
- Prepare, review, and maintain design documentation including specifications, drawings, protocols, reports, DHF, and DMR documents.
- Drive design change management activities through engineering change requests/orders and ensure proper documentation updates.
- Perform risk management activities, including Hazard Analysis and Design Failure Mode & Effects Analysis (DFMEA).
- Support DHF/DMR remediation projects to ensure regulatory compliance and data integrity.
- Collaborate with cross-functional teams including R&D;, Quality, Regulatory Affairs, Manufacturing, and Supplier Quality.
- Utilize Windchill or other Product Lifecycle Management (PLM) tools for document and product data management.

Preferred candidate profile

- Bachelor's or Master's degree in Mechanical Engineering.




- 5-7 years of experience in Mechanical Product Design and Development.
- Hands-on experience with Medical Device Design Control processes.
- Robust understanding of Design Change Management and Engineering Change procedures.
- Experience in Risk Management methodologies and DFMEA.
- Knowledge of Design History File (DHF) and Device Master Record (DMR) remediation activities.
- Proficiency in Windchill or equivalent PLM systems.
- Experience working in regulated environments, preferably Medical Device industry.
- Strong documentation, analytical, and problem-solving skills.
- Excellent verbal and written communication skills.
- Ability to work effectively in cross-functional and global teams.
- Familiarity with FDA, ISO 13485, and medical device quality system requirements is an added advantage.

📌 Design Engineer (Pune)
🏢 Infosys
📍 Pune