Job Overview
We are seeking a highly motivated and detail-oriented Design Engineer specializing in Ophthalmology to join our innovative medical device development team. In this role, you will be instrumental in designing, developing, and refining ophthalmic surgical instrumentation that enhance patient care and improve clinical outcomes. Your expertise will contribute to creating cutting-edge solutions that meet rigorous safety standards and optimize functionality for ophthalmic procedures. This is an exciting opportunity for a passionate engineer eager to make a meaningful impact in eye health technology through active collaboration, creative problem-solving, and technical excellence.

Responsibilities

• Collaborate with cross-functional teams including clinicians, product managers, and manufacturing to develop innovative ophthalmic device designs that align with clinical needs and regulatory standards.
• Utilize optical experience and anatomy knowledge to design precision components for ophthalmology instruments, ensuring optimal performance and patient safety.
• Apply engineering principles to create detailed CAD models, prototypes, and test plans for new ophthalmic products.
• Conduct thorough feasibility analyses, risk assessments, and validation testing to ensure designs meet safety, efficacy, and usability standards.
• Incorporate medical terminology, physiology knowledge, and aseptic techniques into design processes to enhance device sterility and functionality.
• Maintain comprehensive documentation of design iterations, technical specifications, and compliance records in accordance with FDA regulations and medical coding standards.
• Support manufacturing teams during production ramp-up by providing technical guidance on design specifications and quality control measures.
• Create detailed engineering drawings, specifications, and documentation following regulatory and quality standards (ISO 13485, FDA 21 CFR Part 820).
• Conduct feasibility studies, tolerance analyses, and design verification activities.
• Develop prototypes and coordinate with internal teams and external vendors for fabrication.
• Perform design verification and validation testing, including test method development.
• Support risk management activities (FMEA, fault‑tree analysis).
• Participate in design reviews and contribute to design history file (DHF) documentation.
• Collaborate with R&D, manufacturing, quality, regulatory, and clinical teams.
• Troubleshoot design issues and support root‑cause investigations.
• Ensure designs meet safety, performance, biocompatibility, and sterilization requirements.

Experience

• Proven experience in optical engineering or ophthalmology device design within a medical or healthcare environment.
• Demonstrated ability to work effectively in multidisciplinary teams with excellent communication skills.
• A solid understanding of anatomy knowledge, physiology principles relevant to ophthalmology, and medical terminology essential for designing patient-centered devices. Join us as a Design Engineer in Ophthalmology where your innovative spirit will help shape the future of eye care technology! We are committed to fostering a dynamic environment that values your expertise while supporting your professional growth through comprehensive training and collaborative projects. All positions are paid roles dedicated to advancing health solutions that truly make a difference.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 2+ years of experience in medical device design; ophthalmic device experience preferred.
• Proficiency in CAD tools (e.g., SolidWorks, Creo).
• Knowledge of DFM/DFA principles and medical device regulatory requirements.
• Experience with prototyping, materials selection, and test development.
• Strong analytical, problem‑solving, and communication skills.

Preferred Skills

• Experience with micro‑mechanisms, precision machining, or disposable instrument design.
• Familiarity with optical systems or ophthalmic surgery workflow.
• Understanding of sterilization methods (EtO)

Pay: $90,000.00 - $110,000.00 per year

Benefits:

• Health insurance
• Paid time off

Work Location: In person