Website:
zydusmedtech.com
Job details:
Title: Mechanical Simulation & Design Architect
Are you a visionary Design Engineer driven by the passion to enhance patients' lives through groundbreaking medical devices? At Zydus MedTech R&D, your passion finds its purpose. Join us to design, develop, and test advanced mechanical systems for next-generation medical devices, working closely with a leadership team that brings over 100 years of collective experience and collaborates with India’s premier research institutes.
As a Mechanical Simulation & Design Architect in the medical device domain, you will lead the design and development of innovative technologies that tackle complex healthcare challenges. Your design engineering and simulation expertise will be pivotal in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance. Collaborating with cross-functional teams-including 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, develop, and optimize mechanical systems and sub-systems for medical devices from concept to production.
- Run simulations using Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) in addition to Creating 3D models and detailed drawings using CAD software.
- Test designs for stress, strain, fatigue, thermal, and fluid dynamics, to optimize mechanical designs and ensure proper function.
- Find flaws in virtual models before manufacturing starts and Work with designers to improve part strength and shape.
- Compare data from computer models with real physical test results, Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
- Selecting appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
- Staying up to date with the latest advancements in materials science, plastic technologies, and manufacturing processes.
- Conduct rigorous testing and verification of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, EUMDR, CDSCO, ISO 13485).
- Ensure that all design and development activities adhere to relevant medical device regulations and standards.
- Participate in continuous learning and development within the field of medical devices.
Skills & Qualifications:
To excel in this role, you should possess the following qualifications:
- Bachelor’s or Master’s degree in Mechanical Engineering from 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.
- Expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g. ANSYS, COMSOL).
- Strong skills in design calculations, GD & T and tolerance stack up analysis.
- Experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.
- Strong understanding of plastic component designs for medical devices.
- 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.
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