Merck · 9 hours ago
Sr. Scientist, Drug/Device Combo Pdts
USA - New Jersey - Rahway
Full-time
Onsite
Mid, Senior Level
$117K/yr - $184K/yr
6+ years expMerck is a leading biopharmaceutical company dedicated to research and innovation. They are seeking a Senior Scientist to join their Device Development & Technology Team, focusing on the characterization and testing of drug delivery devices and combination products. The role involves utilizing advanced analytical techniques to assess device performance and identify areas for improvement.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
No H1B
Responsibilities
Responsible for technical interrogation of the various drug delivery device technology platforms supporting the pipeline to identify risks and opportunities for improvement
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
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
Experience training junior staff on instrumentation operation and data analysis/interpretation best practices
Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes
Qualification
Required
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
Deep technical understanding of test method development and qualification/validation/transfer techniques
Fluency with mechanical testing, imaging, and measurement equipment and techniques. Including, but not limited to, force/tension/compression testing, rhinometry, 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 operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (ex Keyence / Cognex), Bouncer, and drop shape analyzers
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, ISO 11608
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
Pharma Letter
2026-02-13
2026-02-12
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