Summary

This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically through mechanical or electro-mechanical means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Job description

Role Summary

This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company pipeline to identify risks and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments, methods, and extensive data analysis/interpretation to build fundamental understanding of the device’s material and functional properties and attributes. Many of the drug delivery device technology platforms are often assemblages of injection molded plastic components driving delivery of a drug, typically through mechanical or electro-mechanical means. Examples include, but not limited to, injector pens, on-body injectors, and inhalers. At this early stage of evaluation material is often limited and will demand creative approaches.

Education Requirement

B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.

Required Experience And Skills

A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.
Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.
Deep technical understanding of test method development and qualification/validation techniques.
Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.
Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Preferred Experience And Skills

Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, drop shape analyzers, spectrophotometers, and rheometers.
Develop innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA’s) for all finished product performance test methods as needed in tech transfer or lifecycle.
Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use.
Additional familiarity/experience with the following industry related knowledge is a plus: 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics, ISO 13485, ISO 14971, ISO 11040, ISO 10993, PSCS

Requirements

B.S., M.S. or Ph.D. in Mechanical Engineering or equivalent field is required.
A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and mechanical testing/test method development experience.
Exceptional mechanical testing and troubleshooting skills able to work independently in a laboratory setting.
Experience training junior staff on instrumentation operation and data analysis/interpretation best practices, including statistical analysis techniques.
Deep technical understanding of test method development and qualification/validation techniques.
Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rheometry, and microscopy.
Excellent collaboration, ideation, and prototyping skills, including fixture development for functional testing.
Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
Other Insurance Benefits
401(k)
Paid Holidays
Vacation
Compassionate Leave
Sick Leave
Annual Bonus
Long-Term Incentive

Company overview

Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.