Director/Sr. Director, Medical Device Development

Liquidia

11d

About The Position

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives. The Senior Director or Director of Medical Device Development will lead the development and lifecycle management of inhalation drug delivery systems, with a strong focus on inhalation technologies and drug–device combination products. This role is responsible for driving robust inhalation device development and innovation, and ensuring compliance with the latest regulations for the successful combination use of device and drug across all development stages, from early feasibility. The role also requires deep technical expertise in nebulizers, DPIs and SMIs, aerosol science, device engineering, statistics and combination product development.

Requirements

PhD, MS, or equivalent degree in Industrial Design, Mechanical Engineering, Electrical Engineering, Human Factors Engineering, Aerosol Science, Pharmaceutical Sciences, Statistics, or another relevant field.
Proven track record (15+ years) in development of medical devices, including mesh nebulizers, SMIs, and drug-device combination products.
Experience supporting regulatory submissions and responding to deficiencies related to inhalation devices and inhaled drug-device combination products.
Proven ability to lead cross-functional development programs and provide support for commercial launches.
Mesh nebulizer technology (including mechanical, electrical, and software engineering)
SMI engineering
Human factors engineering
Design controls, risk management and preparation of DHF authoring
Design verification and validation
Statistics for samples size calculations and SPEC settings as applied to the development of medical devices and combination products
CFR 820. Part 4 / ISO 13485, medical devices quality framework and in-depth knowledge of GMP, GXP, FDA and EU regulatory requirements for medical devices
Strong program leadership and decisive decision-making
Management of external device partners
Excellent communication and stakeholder management

Responsibilities

Collaborates in developing device development strategies that support and align with pipeline needs.
Acts as the technical lead for nebulizers, SMIs, other inhalation delivery technologies, and oversees mechanical, electrical, software, human factors engineering, as well as statistical analysis of sample sizes for design verification.
Oversees device design, prototyping, verification, validation, and transfer processes.
Ensures development of drug–device combination products follow design control and risk management requirements in accordance with FDA and international regulations.
Leads preparation of Design History File (DHF).
Identifies issues and proposes mitigating plans to facilitate decision-making
Works collaboratively with contract development and manufacturing organizations (CDMOs) and device vendors.
Drives cross-functional alignment among R&D, Clinical, Quality, Regulatory, and Manufacturing teams.
Supports preparation of device sections for regulatory filings and responses to deficiencies.