Lead Mechanical Design Engineer

Position Overview:
The Client is seeking a dynamic and experienced Lead - Mechanical Design Engineer to spearhead the mechanical development of innovative and accessible medical devices. With a strong foundation in plastic part design, this role demands technical leadership in design, prototyping, analysis, and production readiness. The ideal candidate will have deep expertise in medical device development and a passion for creating impactful healthcare technologies.

About Client:

A rapidly growing health-technology innovator developing next-generation ophthalmic imaging platforms that integrate advanced optics, precision mechanical design, embedded electronics, and AI-driven diagnostics. Our cloud-connected systems enable scalable, high-quality screening for major eye diseases across diverse clinical environments. We bring together mechanical, electrical, and software engineers alongside researchers and clinicians to solve complex challenges in medical imaging, mechatronics, and machine learning—advancing global eye-care accessibility through cutting-edge technology and real-world impact.

Key Responsibilities:

• Lead the end-to-end mechanical design and development of medical devices, from concept through production.

Ensure designs meet regulatory standards (ISO 13485, IEC 60601-1) and design control requirements for medical devices.

• Collaborate with electrical, software, industrial design, and clinical teams to deliver integrated solutions.
• Own and drive the design of plastic components and assemblies, focusing on material selection, DFM/DFA, and cost-efficiency.
• Conduct detailed engineering analyses: FEA, GD&T, tolerance stack-up, thermal analysis, and failure mode analysis.
• Develop and maintain 3D CAD models, 2D drawings, specifications, and BOMs using tools such as SolidWorks.
• Guide and participate in design reviews, risk management, and V&V activities.
• Interface with vendors and manufacturing partners to translate design into manufacturable solutions.
• Mentor and support a team of junior engineers and interns, fostering technical growth and best practices.
• Contribute to innovation through rapid prototyping, design iteration, and usability improvements.

Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering or a related field.
• 8+ years of mechanical engineering experience, with a proven track record in medical device development.
• Expertise in plastic design: materials, injection molding, DFM, and tolerancing for high-precision parts.
• 3+ years of proficiency in SolidWorks and engineering analysis tools (e.g., ANSYS, COMSOL).
• In-depth understanding of regulatory compliance in medical device development (ISO 13485, IEC 60601-1).
• Strong project ownership and ability to manage multiple priorities in a fast-paced environment.
• Exceptional problem-solving skills and a high degree of attention to detail.
• Strong verbal and written communication skills, with experience in cross-functional team collaboration.

Preferred Qualifications:

• Hands-on experience with rapid prototyping tools and additive manufacturing techniques.
• Familiarity with human factors engineering and usability testing in medical devices.
• Experience working in an Agile product development environment

Job Types: Full-time, Permanent

Benefits:

• Health insurance
• Paid sick time
• Provident Fund

Experience:

• Mechanical design: 8 years (Preferred)
• Solidworks: 3 years (Preferred)

Work Location: In person