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Principal Medical Device Design Specialist

2 weeks ago

Vizag, Andhra Pradesh, India beBeeMechanicalArchitect Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Opportunity:

Enhance patient care through groundbreaking medical device innovation.

As a Mechanical Architect, you will lead the development of innovative technologies to tackle complex healthcare challenges. You will conceptualize, design, develop, and optimize mechanical systems and sub-systems for medical devices from concept to production.

Key Responsibilities:

  • Designing new products or components to meet specific performance, aesthetic, and functional requirements.
  • Creating 3D models and detailed drawings using CAD software like Solidworks / CreO.
  • Conduct engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function.
  • Developing and optimizing products in sheet-metal, machining and plastic processing techniques (e.g. injection molding, extrusion, blow molding, thermoforming, and other plastic processing techniques).
  • Staying up to date with the latest advancements in materials science, plastic technologies, and manufacturing processes.
  • Conduct rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards.
  • Creating and maintaining accurate and comprehensive documentation of designs, specifications that includes interface design and specifications, test procedures, and verification reports for medical devices.
  • Ensuring that all design and development activities adhere to relevant medical device regulations and standards.
  • Contributing to the development of new and innovative medical device technologies.

Requirements:

  • Bachelor's or Master's degree in Mechanical Engineering from a reputed Institute.
  • Minimum of 8-12 years of prior experience in MEDICAL DEVICE design and development, with a strong understanding of regulatory requirements and standards.
  • Strong skills in design calculations, GD & T and tolerance stack up analysis.
  • Expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g. ANSYS, COMSOL).
  • Experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.
  • Strong understanding of plastic component designs for medical devices, 3D printing and scanning of components for reverse engineering.
  • In-depth understanding of medical device regulations, standards, and certification processes.

Essential Skills:

  • Excellent analytical and problem-solving abilities to tackle complex design challenges.
  • Strong interpersonal and communication skills to collaborate effectively with cross-functional teams.
  • Meticulous approach to design and documentation to ensure precision and regulatory compliance.