Product Development Engineer
Description

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, has initiated a Phase 3 clinical trial for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 clinical development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.


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

  • 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 bioresorbable 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 
  • Assist in risk management activities and deliverables
  • Assist in the preparation of regulatory submissions, scientific/engineering papers, grant applications, invention disclosures, and patents
  • 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
Requirements
  • 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
  • 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
  • Collaborative team player who enjoys working in a highly dynamic, cross-disciplinary environment
  • Must be able to analyze / synthesize data and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient manner

At 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.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.