Senior Director, R&D Engineering

About SpyGlass Pharma:

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.

We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn’t just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.

This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.

Summary:

We are seeking a Director or Senior Director of R&D Engineering to lead development of our ophthalmic implantable device platforms and intraocular lens (IOL) technologies. Reporting to the Chief Research & Development Officer, this role will be responsible for driving medical device and combination product development from concept through approval and commercialization. The ideal candidate will bring extensive technical and leadership experience in ophthalmology, with a successful track record of bringing products through design, testing, regulatory submission, and market launch.

Essential Duties & Responsibilities:

• Lead the R&D Engineering function focused on ophthalmic drug delivery and IOL devices from concept through development and commercialization.
• Define and execute engineering strategies and technical roadmaps for device innovation, integrating mechanical, optical, and drug delivery technologies.
• Oversee design and development activities, ensuring design inputs/outputs, risk management, and documentation are compliant with design control requirements.
• Drive technical problem-solving and innovation in product development, ensuring safety, performance, and user-centric design.
• Collaborate with cross-functional teams including Pharmaceutical Development, Clinical Affairs, Regulatory, Quality, and Manufacturing.
• Manage and mentor a team of engineers and technical staff, fostering a high-performing and innovative culture.
• Support vendor selection and management, including design partners and contract manufacturers, ensuring timely and quality deliverables.
• Guide verification and validation activities, including test development, protocol execution, and design transfer to production.
• Represent R&D Engineering in cross-functional meetings and project reviews, providing clear technical leadership and updates.
• Ensure adherence to applicable regulatory standards including ISO 13485, FDA QSR, and EU MDR for combination products.
• Maintain awareness of industry trends and advancements to inform future product innovation.
  

Qualifications Required For Position:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field; advanced degree preferred.
• Minimum of 15 years of experience in medical device R&D, with at least 5 years in a leadership role.
• Proven experience in full lifecycle medical product development, including regulatory approval and commercial launch.
• Demonstrated success in the development of ophthalmic devices and/or drug-device combination products.
• Deep understanding of design controls, risk management, and regulatory requirements for Class II/III medical devices.
• Strong knowledge of device manufacturing methods, materials, and testing strategies.
• Excellent leadership, project management, and communication skills.
• Proficiency in CAD tools (e.g., SolidWorks) and engineering analysis software.
• Ability to work in a fast-paced, collaborative environment with multiple priorities.
  

Why SpyGlass Pharma?

• We are offering a range of $225,000 - $250,000, 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.

SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.

SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to JOBS@SPYGLASSPHARMA.COM and let us know the nature of your request and your contact information.

Salary : $225,000 - $250,000