Senior Engineer, R&D
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Job Location:
Aliso Viejo, CA - USA
Monthly Salary:
$ 120 - 140
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 professionalswith 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 doesnt 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 $200 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:
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.
Essential Duties & 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.
Qualifications Required For Position:
- 4-5 years of engineering experience in the medical device or combination product industry with demonstrated ownership of complex device development projects.
- Bachelors or Masters 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.
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 and let us know the nature of your request and your contact information.
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
