
Visionary Mechanical Systems Designer
2 weeks ago
Innovative Medical Device Designer
You will conceptualize and develop mechanical systems that tackle complex healthcare challenges.
Your design expertise will be pivotal in crafting devices that uphold the highest standards of performance, safety, and regulatory compliance.
Key Responsibilities:
- Designing new products or components to meet specific requirements.
- Creating 3D models and detailed drawings using CAD software.
- Conduct engineering analyses to optimize designs and ensure proper function.
- Selecting materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
- Developing and optimizing products in sheet-metal, machining and 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 and compliance with relevant medical device standards.
- Create and maintain accurate documentation of designs, specifications, test procedures, and verification reports for medical devices.
- Prepare progress reports, technical presentations, and updates for project stakeholders.
- Ensure that all design and development activities adhere to relevant medical device regulations and standards.
Requirements:
- Bachelor's or Master's degree in Mechanical Engineering from a reputable institution.
- Minimum of 8-12 years of experience in MEDICAL DEVICE design and development.
- 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 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.
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