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Senior Engineer, New Product Development

Spyglass Pharma

Spyglass Pharma

Product
Aliso Viejo, CA, USA · Aliso Viejo, CA, USA · United States
Posted on Wednesday, June 5, 2024

About SpyGlass Pharma:

At SpyGlass Pharma, we are actively engaged in projects addressing unmet needs in glaucoma and cataract surgery/intraocular lens replacement, striving for paradigm shifts in global eye care.

Our team comprises professionals with diverse expertise in ophthalmic devices and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology, IOL development, and commercial success. Led by a proven team with expertise in science, R&D, communications, and operations, SpyGlass Pharma™ takes ideas from inception through commercialization.

Our commitment to actively improving patients’ quality of life drives the company to innovate and succeed.

Learn more at www.spyglasspharma.com

Summary:

The Senior Engineer, New Product Development will be responsible for projects focused on next generation and pipeline products. The Sr. Engineer will work with the Sr. Director, R&D Engineering and Chief Technology Officer to define, prioritize and execute research projects. In addition to the research activities, the Sr. Engineer may contribute to the implantable drug delivery and IOL products development teams. For both, responsibilities include ensuring quality, safety, and regulatory compliance of products throughout the product lifecycle.

Essential Duties & Responsibilities:

  • Plan research projects, including timeline, budget, and deliverables.
  • Execute projects to plan with appropriate collaboration and communication. This includes conducting feasibility studies, designing prototypes, and performing initial risk assessments.
  • Collaborate with internal teams, to align project goals and ensure seamless product development. Communicate effectively with stakeholders, including presenting project updates, technical reports, and compliance documentation.
  • Establish verification and/or validation protocols, conduct testing, and analyze data to ensure process robustness and repeatability.
  • Maintain accurate and comprehensive documentation throughout the product development process, including design specifications, drawings, test protocols, and reports. Prepare technical reports and presentations to effectively communicate project status and findings.
  • Stay updated with relevant regulations, standards, and guidelines. Ensure the design and manufacturing processes adhere to these requirements, including documentation, risk management, and quality management system compliance.

Qualifications Required For Position:

  • 3 years of experience in the development and manufacturing of medical products.
  • Experience developing medical products for ophthalmic applications with good working knowledge of eye anatomy.
  • Strong knowledge of common manufacturing methods and design best practices.
  • Familiarity with relevant regulations and standards.
  • Experience with design control and risk management.
  • Proficiency in using design software (e.g., SolidWorks) and statistical analysis tools.
  • Excellent problem-solving skills and ability to work in a fast-paced, multidisciplinary team environment.
  • Strong communication skills, both written and verbal, with the ability to effectively present technical information to diverse audiences.
  • Attention to detail, accuracy, and commitment to producing high-quality deliverables.

Certificates/Licenses Required For Role:

  • Bachelor’s or master’s degree in mechanical engineering or related field.

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.