Sr. Engineer - Combination Product Inhalation Device Lead

Location: US - Massachusetts - Cambridge

Salary: $127,044.40–$171,883.60 annually

Company

hirify.global is a biotechnology company developing and manufacturing medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead systems engineering and device development for dry powder inhaler combination-product programs.
• Translate patient and user needs into system requirements, interface definitions, design outputs, risk controls, and verification strategies.
• Own Design History File and Design and Development Plan deliverables for the inhaler device constituent.
• Lead drug-device-capsule integration, including airflow, aerosolization, dose delivery, usability, and performance interfaces.
• Assess supplier design, verification, manufacturing, and master-file evidence, identifying applicability gaps and bridging needs.
• Coordinate with regulatory, quality, drug product, analytical, manufacturing, clinical, human factors, and supplier stakeholders.

Requirements

• Doctorate degree, or a master's degree with 2 years of engineering experience.
• Bachelor's degree with 4 years, associate's degree with 8 years, or high school diploma/GED with 10 years of engineering experience.
• Experience with capsule-based or other dry powder inhaler platforms and combination products through development, verification, and regulatory submission.
• Knowledge of aerosol performance characterization, including delivered dose uniformity, aerodynamic particle size distribution, and device resistance or pressure-flow testing.
• Experience with design controls, requirements traceability, risk-based bridging, configuration and change control, and supplier technical oversight.
• Knowledge of fluid dynamics, aerosol science, particle dispersion or deagglomeration, and inhalation delivery systems.

Nice to have

• Experience supporting FDA or global regulatory submissions for drug-device combination products.
• Experience with platform-device strategies and master-file applicability assessments.
• Experience mentoring technical teams or serving as a subject matter expert in combination-product systems engineering.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus opportunities and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.