KEY RESPONSIBILITIES
1. Leadership & Strategy
a) Together with Mech Manager, provide technical guidance to a high-performing ME team.
b) Define the ME team’s long-term strategy aligned with corporate goals in ophthalmic imaging and surgical devices.
c) Foster a culture of innovation, accountability, and technical excellence.
2. Technical Execution
a) Oversee the design and development of precision mechanical systems for ophthalmic imaging and surgical platforms.
b) Drive robust product architecture, design for manufacturability (DFM), and reliability engineering.
c) Ensure integration of optics, electronics, and software into cohesive system designs.
d) Provide technical guidance on materials, tolerance stack-up, thermal management, vibration control, and ergonomics.
3. Project Management & Collaboration
a) Partner with Program Management, Optical Engineering, Electrical Engineering, and Software teams to deliver projects on time and within budget.
b) Support clinical, regulatory, and quality teams with technical documentation required for FDA 510(k), CE, and other regulatory submissions.
c) Coordinate with external design partners, suppliers, and manufacturing vendors to ensure scalable production readiness.
4. Quality & Compliance
a) Ensure all ME work adheres to ISO 13485, FDA QSR, and relevant medical device standards.
b) Implement best practices in risk management and design controls.
c) Promote continuous improvement processes within the ME team.
Qualifications
● Master’s degree in Mechanical Engineering (PhD preferred).
● 10+ years of progressive ME experience (with 5-years leadership experience is a big plus)
● Demonstrated track record of development of complex electro-mechanical medical devices; ophthalmic device or robot experience strongly preferred.
● Deep knowledge of opto-mechanics, precision mechanisms, and system integration.
● Experience with GD&T, tolerance analysis, FEA, thermal/fluid analysis, and reliability testing.
● Strong understanding of regulatory pathways (FDA, CE) and design control processes.
● Excellent communication, and cross-functional collaboration skills.