About the Role
We are seeking a detail-oriented and technically proficient Design Engineer to support the full product development lifecycle of medical devices. From Gap Assessments and Design Controls to Engineering Documentation and Acquisition Integration, you will play a hands-on role in delivering high-quality, regulation-compliant design solutions for global clients. This is an excellent opportunity for an engineer passionate about meaningful work at the intersection of precision engineering and healthcare.
Key Responsibilities
- Collaborate with a global engineering team operating under an Onshore–Offshore delivery model
- Lead or support new product development and equipment design for medical devices
- Create Conceptual Sketches, 3D Models, Assemblies, Engineering Drawings, Design Documents, Simulations, and Machine Manuals
- Perform Tolerance Stack Analysis and ensure designs are optimized for manufacturability
- Support design and manufacturing teams across all phases of design operations using proven techniques
- Conduct product design and development in compliance with CE & FDA regulations governing medical devices
- Participate in regular global team meetings to communicate priorities, align on customer requirements, and set clear deliverable expectations
- Resolve technical queries and customer concerns, driving projects through to successful completion
- Maintain up-to-date knowledge of key international standards, regulatory guidance, and medical electrical equipment requirements
- Understand customer specifications and proactively recommend improvements to existing design concepts
Requirements
- 4–5 years of experience in design engineering projects with strong execution capability
- Solid understanding of core mechanical design principles — dimensioning, tolerancing, and material properties
- Proficiency in 3D CAD modeling, preferably SolidWorks
- Hands-on experience with Tolerance Analysis, GD&T, and Value Engineering
- Knowledge of plastic and sheet metal part design and associated manufacturing technologies
- Working knowledge of FDA, GMP, and ISO 13485 standards
- Experience with basic statistics, reliability methodologies, and technical writing
- Strong written and verbal communication, presentation, and coordination skills
- Ability to manage customer requirements and deliver on time with high attention to detail
- Bachelor’s degree in Engineering or any advanced engineering discipline