24 Aug
|
Aviyana Ventures
|
Vasai-Virar
24 Aug
Aviyana Ventures
Vasai-Virar
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)
🏢 Aviyana Ventures
📍 Vasai-Virar