Design Engineer

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.
• Strong 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.