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Senior Product Development Engineer
2 months ago
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.
Key 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 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.
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.
- 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.
