- Apply sound engineering principles and practices to the design, development, and testing of biomaterials-based, drug delivery implants, and their delivery systems
- Develop, set-up, and utilize bench and preclinical models to evaluate performance of innovative bioabsorbable therapies
- Manage product development activities with external vendors
- Document development activities in technical reports and lab notebooks
- Write work instructions, test methods, batch records, study protocols and other technical documents related to product development and manufacturing
- Lead design control deliverables as products progress through development
- Lead/assist in risk management activities and deliverables
- Lead/assist in the preparation of regulatory submissions, scientific/engineering papers, grant applications, invention disclosures, and patents
- Lead/assist in the upgrade of current delivery system and in the design of next generation delivery systems
- Execute timelines and milestones as part of project planning
- Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design and manufacture of human use products
- Manage suppliers on the design and procurement of tooling and fixtures that aid in product development, testing, and/or inspection
- 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 products
- Highly knowledgeable in Design Control with experience taking products through Design Verification and Validation
- Areas of expertise: product, process and test method development as well as mechanical design, prototyping, biomaterials
- Knowledge and experience in biomedical test method development, validation, and execution
- Experience and working knowledge of the U.S. and International standards governing the design, development and manufacture of drug products and medical devices
- Ability to work on multiple projects simultaneously, prioritize assignments, and adapt in a fast-paced environment
- Excellent written and verbal communication skills
- Experience using SolidWorks
- Collaborative team player who enjoys working in a highly dynamic, cross-disciplinary environment
- Must be able to analyze and interpret data, apply sound statistical techniques, and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient manner
Senior Product Development Engineer - Waltham, United States - Lyra Therapeutics
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 naïve 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.
Responsibilities