Senior Engineer, R&D

Spyglass Pharma • Aliso Viejo, CA

3d • $120,000 - $140,000 • Hybrid

About The Position

The Senior Engineer, R&D will lead complex engineering efforts that support the development of novel ophthalmic medical devices at SpyGlass Pharma. This position plays a critical role in experimental design, problem-solving, and project execution, while mentoring junior team members and ensuring engineering excellence across R&D initiatives. The successful candidate will demonstrate deep technical expertise and a collaborative approach to achieving device engineering milestones from concept through clinical evaluation.

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.

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.

Benefits

• We are offering a range of $120,000 - $140,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the company’s future.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1-10 employees