- Design & Development: Design, model, and prototype precision mechanical components, optical mounts, and housings for ophthalmic instruments using 3D CAD software (SolidWorks/Creo).
- Opto-Mechanical Engineering: Perform opto-mechanical design tasks, including lens barrel design, lens mounting techniques, and tolerance studies to maintain optical alignment.
- Analysis & Simulation: Conduct Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) to analyse stress, thermal behaviour, and vibration, ensuring device reliability.
- Documentation & Compliance: Create, maintain, and manage technical documentation (specifications, drawings, BOMs) and ensure compliance with FDA 21 CFR 820.30 and ISO 13485 standards.
- Prototyping & Testing: Support prototype builds, design iterations, and validation testing to meet performance, safety, and regulatory requirements.
- DFM/DFA: Collaborate with manufacturing teams to optimize designs for manufacturability (DFM) and assembly (DFA), including injection molding, plastics, and precision machining.
- Risk Management: Participate in Failure Mode and Effects Analysis (DFMEA/FMEA) to minimize operational risks.
- Bachelor's or master’s degree in mechanical engineering.
- Previous experience designing ophthalmic surgical tools or diagnostics.
- 10+ years of experience in mechanical design, preferably within the medical device or optical industry.
- Highly proficient in 3D CAD modelling software (e.g., SolidWorks, Creo).
- Hands-on experience with precision machining, injection molding, or small-part assembly.
- Strong understanding of geometric dimensioning and tolerancing (GD&T).
- Experience with PLM software
Qualification:
- Paid Leave
- Health Insurance
- Group life insurance
- Disability
- 401(K)
The expected salary range for this position is between $70,000 to $1,20,000 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.