Senior Device Engineer — OINDP & Drug-Device Innovation

Transpire BIO Inc.; Florida; On-site; USD 110,000 - 170,000; Full time

Job summary

Transpire BIO Inc. in Florida is seeking a Senior Device Engineer to lead device development for orally inhaled and nasal drug products (OINDPs), from early R&D through commercialization.

This hands-on role requires designing, prototyping, testing, and documentation to meet FDA and ISO requirements. You will collaborate with cross-functional teams, conduct analyses, support scale-up, and contribute to design history files, SOPs, and regulatory submissions, while driving quality and

Qualifications

• MS in Mechanical Engineering or related field with 7–10 years device development experience.
• B.S. with 10–14 years device development experience in pharmaceutical or related field.
• Expert knowledge of mechanical design; SolidWorks preferred.
• Expert knowledge of tools to conduct statistical and tolerance analysis.
• Knowledge of manufacturing processes including injection molding and metal machining.
• Knowledge of regulations and standards including US 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, EU MDR.

Responsibilities

• Provide technical leadership in the device development area.
• Execute design and development of orally inhaled and nasal drug products (OINDPs) following design controls.
• Lead and execute analysis for device and product characterization, design feasibility, and design verification.
• Lead root cause investigations.
• Support scale-up and commercialization efforts.
• Document studies and author documents per US FDA, EMA, MHRA and other global health authority requirements.
• Interface and lead activities with third party contract research, development, and manufacturing organizations.

Skills

SolidWorks

Statistical analysis

Tolerance analysis

Injection molding

Metal machining

Regulatory compliance

Cross-functional leadership

Education

MS in Mechanical Engineering

Bachelor's degree in Engineering

Job description

Transpire BIO Inc. in Florida is seeking a Senior Device Engineer to lead device development for orally inhaled and nasal drug products (OINDPs), from early R&D through commercialization.

This hands-on role requires designing, prototyping, testing, and documentation to meet FDA and ISO requirements. You will collaborate with cross-functional teams, conduct analyses, support scale-up, and contribute to design history files, SOPs, and regulatory submissions, while driving quality and