Medical Device Mechanical Engineer

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.