Mechatronics Design Engineer

Role & responsibilities

Job Summary:-

As a Mechatronics Design Engineer in the medical device domain, you will lead the development of innovative technologies that tackle complex healthcare challenges. Your design engineering expertise will be pivotal in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance. Collaborating with cross-functional teamsincluding R&D, Quality Assurance, and Regulatory Affairs—you will play a key role in transforming visionary concepts into market-ready medical solutions.

Key Responsibilities:

In this pivotal role, your primary responsibilities will include:

• Conceptualize, design, and optimize mechatronic systems for medical devices, including mechanical components, electrical circuits, and software control.
• Work closely with cross-functional teams, including electrical engineers, software engineers, and manufacturing teams, to integrate hardware and software.
• Conduct rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, ISO 13485).
• Create and maintain accurate and comprehensive documentation of mechatronics system designs, specifications that includes interface design and specifications, test procedures, and verification reports for medical devices. Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
• Diagnose and resolve technical issues, troubleshoot problems with mechatronic systems, and propose solutions to improve performance.
• Ensure that all design and development activities adhere to relevant medical device regulations and standards.
• Contribute to the development of new and innovative medical device technologies.
• Participate in continuous learning and development within the field of medical devices.
• Integrate motor control systems, tune drive controllers to optimize performance, and collaborate on the integration of Mechatronics subsystem hardware and software.
• Experiences with Embedded C/C++, RTOS & Labview .

Skills & Qualifications:

• Bachelor’s or Master’s degree in Mechatronics Engineering.
• Minimum of 5-8 years of prior experience in medical device design and development, with a strong understanding of regulatory requirements and standards. Should have experience in Electromechanical systems, sub-systems design and development.
• Expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD), FEA simulation tools, and programming languages.
• Programming and working with Audrino UNO / Raspberry Pie is a must.
• Experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.
• Strong understanding of sheet metals and plastic component designs for medical devices, 3D printing and scanning of components for reverse engineering.
• Strong GD & T and tolerance stack up analysis.
• In-depth understanding of medical device regulations, standards, and certification processes. Familiarity with FDA regulations (e.g., 21 CFR Part 820), ISO 13485 standards, CE marking requirements and applicable international standards (e.g., IEC 60601).
• Strong analytical and problem-solving abilities to tackle complex design challenges.
• Excellent interpersonal and communication skills to collaborate effectively with cross-functional teams.
• Meticulous approach to design and documentation to ensure precision and regulatory compliance.
• Strong problem-solving, analytical, and communication skills.