Medical Device Mechanical Engineer
Kolkata, West Bengal, India
Job Type
Permanent
Responsibilities
Product Design and Development
Design, develop, and verify medical devices from concept to production, ensuring adherence to regulatory standards (ISO 13485, FDA).
Create detailed 3D models and engineering drawings using tools like SolidWorks or Creo.
Perform tolerance stack-up analysis, fluid dynamics simulations, and material selection to optimize product performance.
Cross-functional Collaboration
Work closely with cross-functional teams, including R&D, manufacturing, and quality, to meet performance, reliability, and cost objectives.
Collaborate on technical design reviews, risk assessments (FMEA), and regulatory documentation.
Product Validation and Compliance
Conduct product testing, validation, and verification to ensure design integrity and compliance with international medical device standards.
Identify design gaps and resolve challenges using DFM (Design for Manufacturability) and DFS (Design for Sustainability) principles.
Lifecycle Management
Support existing products by addressing quality improvements, cost reduction, and manufacturing challenges.
Lead initiatives to improve cost, quality, and productivity through innovative engineering practices.
Requirements
Bachelor’s degree in Mechanical Engineering or a related field.
Minimum 3 years of experience in device design and development, with hands-on involvement in the full product lifecycle.
Proficient in 3D CAD software (e.g., SolidWorks, Fusion 360) and familiar with FEA tools.
Strong knowledge of electro-mechanical integration, manufacturing processes (e.g., injection molding, machining, additive manufacturing), and material science.
Experience with quality improvement tools such as FMEA, tolerance stack-up, and DFM principles.
Familiarity with medical device regulatory standards, including ISO 13485 and FDA/CDSCO requirements.
Excellent problem-solving skills and the ability to work independently as an individual contributor.
Effective communication and interpersonal skills, with a proactive approach to innovation.
Preferred Qualifications
Experience with computational fluid dynamics (CFD) and risk-based execution.
Strong project management skills and ability to oversee multiple projects effectively.
Passion for improving user experience through innovative medical device solutions.
About the Company
Vispala Technologies is a pioneering medical device company dedicated to designing and manufacturing cutting-edge prosthetic and orthotic solutions. We strive to enhance lives through innovation, and we are seeking a talented Mechanical Engineer to join our team as an individual contributor, driving excellence in product development and commercialization.