Job Description:

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naí¯ve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.We are looking for a hands-on Product Development Engineer to work on the design and development of a novel transmucosal therapeutic system. The successful candidate must have previous experience developing medical device or combination products, thrive in a fast-paced start-up environment, be adaptable to work on several aspects of product development, and be motivated by the opportunity to learn new technologies.Key Areas of Responsibility:Apply sound engineering principles and practices to the design, development, and testing of biomaterials-based, drug delivery implants, and their delivery systemsDevelop, set-up, and utilize bench and preclinical models to evaluate performance of innovative bioabsorbable therapiesManage product development activities with external vendorsDocument development activities in technical reports and lab notebooksWrite work instructions, test methods, batch records, study protocols and other technical documents related to product development and manufacturingLead design control deliverables as products progress through developmentLeadassist in risk management activities and deliverablesLeadassist in the preparation of regulatory submissions, scientificengineering papers, grant applications, invention disclosures, and patentsLeadassist in the upgrade of current delivery system and in the design of next generation delivery systemsExecute timelines and milestones as part of project planningCollaborate with Quality to ensure compliance to appropriate ISOFDA regulations for the design and manufacture of human use productsManage suppliers on the design and procurement of tooling and fixtures that aid in product development, testing, andor inspection Qualifications:B.S. degree in an Engineering or Scientific field with 5 or more years' of industry experience in the development of medical devices or combination productsHighly knowledgeable in Design Control with experience taking products through Design Verification and ValidationAreas of expertise: product, process and test method development as well as mechanical design, prototyping, biomaterialsKnowledge and experience in biomedical test method development, validation, and executionExperience and working knowledge of the U.S. and International standards governing the design, development and manufacture of drug products and medical devicesAbility to work on multiple projects simultaneously, prioritize assignments, and adapt in a fast-paced environmentExcellent written and verbal communication skills• Experience using SolidWorksCollaborative team player who enjoys working in a highly dynamic, cross-disciplinary environmentMust be able to analyze and interpret data, apply sound statistical techniques, and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient mannerAt Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. For consideration, please submit cover letter and CV. Please visit for more information.