Sr. Scientist, Drug/Device Combo Products (Onsite)

Location: Onsite in Rahway, New Jersey, United States. US and Puerto Rico residents only. No travel required.

Salary: $117,000–$184,200 per year, plus annual bonus and long-term incentive eligibility where applicable.

Company

hirify.global develops healthcare products and technologies focused on improving human health.

What you will do

• Technically evaluate drug delivery device technology platforms, including injector pens, on-body injectors, and inhalers.
• Identify technical risks and improvement opportunities through analytical instruments, testing methods, and data interpretation.
• Characterize device material and functional properties, often using limited material and creative experimental approaches.
• Develop, qualify, and validate mechanical test methods, including fixtures and functional testing prototypes.
• Document test cases according to Good Documentation Practices and provide recommendations for product and design changes.
• Train junior staff on instrumentation operation, data analysis, interpretation, and statistical analysis practices.

Requirements

• B.S., M.S., or Ph.D. in Mechanical Engineering or an equivalent field.
• Ph.D., or M.S. plus 4 years, or B.S. plus 6 years of experience in design, engineering, and mechanical testing or test method development.
• Exceptional mechanical testing and troubleshooting skills, with the ability to work independently in a laboratory setting.
• Experience training junior staff on instrumentation operation, data analysis and interpretation best practices, and statistical analysis techniques.
• Deep technical understanding of test method development and qualification or validation techniques.
• Fluency with mechanical testing, imaging, and measurement equipment, including force, tension, compression, rheometry, and microscopy techniques.
• Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
• Experience with 3D CAD such as SolidWorks, geometric tolerancing, and stack-up analysis.
• Ability to document and analyze test cases and provide comprehensive feedback and recommendations for product or design changes.

Nice to have

• Experience operating and interpreting data from Instron, XRCT, microscopes, vision systems such as Keyence or Cognex, Bouncer, drop shape analyzers, spectrophotometers, and rheometers.
• Experience developing innovative mechanical tests and validations, including engineering studies, design verification protocols, stability studies, and validation protocols.
• Experience selecting acceptance criteria and sampling plans and performing measurement systems analysis for finished-product performance test methods during technology transfer or lifecycle activities.
• Experience with medical device development and Design Controls under 21 CFR 820.30.
• Familiarity with ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, and ISO 11608.
• Additional familiarity with 21 CFR Part 4, 21 CFR 211, FDA guidance for container closure systems, ISO 11040, and ISO 10993.

Culture & Benefits

• Work in an environment focused on ethics, integrity, scientific excellence, inclusion, and improving human health.
• Collaborate with colleagues from diverse experiences and backgrounds.
• Benefits include medical, dental, vision, and other insurance coverage for employees and families.
• Retirement benefits include a 401(k), along with paid holidays, vacation, compassionate leave, and sick days.

Hiring process

• Applications are accepted for the Rahway, New Jersey position.
• Accommodation support is available during the application and hiring process.