25 Aug
|
Aviyana Ventures
|
India
25 Aug
Aviyana Ventures
India
Job Summary
We are looking for a skilled Product Engineer – Medical Devices to support the design, development, testing, validation, and improvement of medical device products. The role will work closely with R&D;, Quality, Regulatory Affairs, Manufacturing, Clinical, and Supply Chain teams to ensure products meet performance, safety, quality, and regulatory requirements.
Key Responsibilities
Design and develop current medical device products and components based on product and clinical requirements.
Convert product requirements into engineering specifications, drawings, prototypes, and design outputs.
Prepare and maintain BOMs, engineering drawings, specifications, design files, and technical documentation.
Support the complete product development lifecycle from concept and prototyping through verification, validation, transfer, and commercialization.
Conduct product testing, verification, validation, reliability testing, and performance evaluation.
Work with the Quality and Regulatory teams to ensure compliance with applicable medical device standards and regulations.
Support Design Control activities, including design inputs, outputs, reviews, verification, validation, and design changes.
Participate in risk management activities, including FMEA and risk analysis.
Identify product defects, investigate failures, and perform root-cause analysis.
Implement corrective and preventive engineering improvements.
Support manufacturing teams during Design Transfer and production scale-up.
Work with suppliers on component development, technical specifications, qualification, and quality issues.
Evaluate materials, components, manufacturing processes, and alternative designs.
Drive product improvements related to performance, reliability, usability, manufacturability, and cost.
Support engineering change requests, ECO/ECN processes, and product configuration management.
Analyze field complaints, customer feedback, and product performance data to
📌 Production Engineer Vasai Virar (India)
🏢 Aviyana Ventures
📍 India