Principal Scientist/Engineer, Drug/Device Combination Products - Device Characterization (Medical Devices)

Location: Rahway, New Jersey, United States of America; US and Puerto Rico residents only.

Salary: $156,900–$247,000 annually, plus eligible annual bonus and long-term incentive.

Company

hirify.global is a global healthcare and biopharmaceutical company developing prescription medicines, vaccines, animal health products, and research-based therapies.

What you will do

• Lead hands-on characterization and design-focused technical interrogation of drug delivery device platforms supporting the product pipeline.
• Identify device failure risks and opportunities for improvement across pre-filled syringes, auto-injectors, on-body injectors, inhalers, and related technologies.
• Use analytical instruments, in silico modeling, mechanical testing, imaging, microscopy, rheometry, surface characterization, and X-ray computed tomography to understand device material and functional properties.
• Analyze and interpret data to design functional improvements and develop new drug delivery technologies.
• Collaborate cross-functionally, communicate complex engineering information in accessible language, and support CMC understanding and project timelines.
• Lead development projects and collaborate with external vendors and research partners in regulated environments.

Requirements

• Ph.D. with 8+ years of industry experience in Mechanical Engineering, Biomedical Engineering, or an equivalent field.
• Proven scientific accomplishments in combination product development, including a strong publication and presentation record.
• Fluency in structural finite element analysis (FEA) and Design Failure Modes and Effects Analysis (FMEA/DFMEA).
• Independent laboratory testing and troubleshooting experience.
• Expertise with mechanical testing, imaging, measurement equipment and techniques, including surface characterization, X-ray computed tomography, rheometry, and microscopy.
• Experience with 3D CAD such as SolidWorks, geometric tolerancing, and stack-up analysis.
• Experience communicating complex engineering information in layman’s terms to support cross-functional CMC understanding and project timelines.
• Development experience in risk-oriented, regulated environments.
• Project leadership experience collaborating with and managing external vendors or research partners.

Nice to have

• Medical device development experience and understanding of Design Controls under 21 CFR 820.30.
• Familiarity with ISO 13485, ISO 14971, EU MDR, and ISO 11608.
• Familiarity with Design Verification strategies, validated mechanical tests, engineering studies, design verification protocols, stability studies, validation protocols, acceptance criteria, sampling plans, and measurement systems analysis for finished-product performance test methods.
• Familiarity with 21 CFR Part 4, 21 CFR 211, FDA guidance for container closure systems, ISO 11040, and ISO 10993.

Culture & Benefits

• Work within a global, research-intensive healthcare and biopharmaceutical organization.
• Collaborate with colleagues across scientific and functional disciplines in an environment emphasizing ethics, integrity, inclusion, and scientific excellence.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.