Advanced Medical Device Designer

Mechanical Design Architect Role Summary:

This is an exceptional opportunity for a visionary Design Engineer to join our R&D team and contribute to the development of groundbreaking medical devices. As a Mechanical Architect, you will play a key role in designing, developing, and testing advanced mechanical systems that enhance patients' lives.

In this pivotal position, you will lead the development of innovative technologies that tackle complex healthcare challenges. Your expertise in design engineering will be instrumental in crafting and optimizing devices that meet the highest standards of performance, safety, and regulatory compliance.

Your primary responsibilities will include:

• Conceptualizing, designing, developing, and optimizing mechanical systems and sub-systems for medical devices from concept to production.
• 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.
• Conducting engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function.
• Selecting appropriate 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 (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.
• Conducting rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, EUMDR, CDSCO, ISO 13485).
• Creating and maintaining accurate and comprehensive documentation of designs, specifications, interface design and specifications, test procedures, and verification reports for medical devices. Preparing progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
• 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.
• Participating in continuous learning and development within the field of medical devices.

Requirements:

To excel in this role, you should possess the following qualifications:

• Bachelor's or Master's degree in Mechanical Engineering from a reputable institution.
• 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. 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.

Benefits:

We offer a dynamic work environment that encourages innovation, collaboration, and growth. As a member of our team, you will have access to cutting-edge technology, opportunities for professional development, and a competitive compensation package.

What We Offer:

A challenging and rewarding career path in a rapidly evolving industry. The opportunity to work with a talented team of professionals who share your passion for innovation and excellence. A collaborative work environment that fosters open communication, creativity, and teamwork. Access to ongoing training and development programs to enhance your skills and knowledge. A competitive salary and benefits package that recognizes your contributions and rewards your hard work. The satisfaction of knowing that your work makes a meaningful difference in people's lives.

Apply Now:

If you are a motivated and experienced Design Engineer looking for a new challenge, please submit your application today. We look forward to hearing from you.