Hybrid Senior Engineer, R&D

at SpyGlass Pharma, Inc.

• Job title: Senior Engineer, R&D
• Job type: Full Time
• Experience level: Senior
• Salary: $120,000 - $140,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Aliso Viejo, United States

About the role

• Senior Engineer leading complex engineering efforts for ophthalmic medical devices at SpyGlass Pharma. Critical role in experimental design, project execution, and mentoring junior team members.

Responsibilities

• Lead the design, planning, and execution of complex experiments and validation studies to support ophthalmic device development.
• Troubleshoot advanced technical issues related to device performance, manufacturing, and testing; identify and implement practical solutions to lab challenges.
• Drive the coordination of R&D engineering projects, ensuring alignment with development timelines, quality standards, and corporate objectives.
• Mentor and train junior engineers, fostering technical growth and excellence in device design and testing methodologies.
• Collaborate cross-functionally with stakeholders in Pharmaceutical Development, Quality, Regulatory, and Clinical to ensure integrated engineering solutions and timely execution of program objectives.
• Develop and maintain design control documentation, including test protocols, reports, and risk analyses, in compliance with regulatory and quality standards.
• Support design verification and validation activities, including the creation of test plans, execution of studies, and analysis of results.
• Maintain up-to-date knowledge of relevant industry trends, engineering tools, and best practices in medical device development.

Requirements

• 4-5 years of engineering experience in the medical device or combination product industry, with demonstrated ownership of complex device development projects.
• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Proven ability to lead engineering initiatives from concept through validation in a regulated environment.
• Strong technical skills in mechanical design, materials selection, and medical device testing.
• Proficiency in CAD software (e.g., SolidWorks), data analysis tools, and standard lab instrumentation.
• Demonstrated leadership and mentoring capabilities with junior engineering staff.
• Excellent written and verbal communication skills, with the ability to clearly present technical information across functions.
• Knowledge of FDA design control regulations, ISO 13485, and risk management per ISO 14971.

Benefits

• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
• Generous paid time off, including holidays, vacation days, and personal leave.
• Annual Bonus opportunity.
• Stock options, giving you a stake in the company’s future.