Sr. Scientist, Drug/Device Combo Pdts

MSD•Rahway, NJ

12h•$117,000 - $184,200•Hybrid

About The Position

Our Company's Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused engineer focused on the characterization and testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products). This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our Company's pipeline to identify risks ( i.e. when/why/how will the device fail) 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 though mechanical ( i.e. compress/torsion spring, compressed gas) or electro-mechanical (i.e. DC motor and battery driving a gearbox) 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. Our Company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our Company's Research Laboratories is a true scientific research facility of tomorrow and will take our Company's leading discovery capabilities and world-class small molecule, biologics, and vaccine R&D expertise to create breakthrough science that radically changes the way we approach disease treatment. Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

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.
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.

Nice To Haves

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

Responsibilities

Technical interrogation of drug delivery device technology platforms to identify risks and opportunities for improvement.
Utilize analytical instruments, methods, and data analysis to build understanding of device material and functional properties.
Documents (following Good Documentation Practices) and analyzes test cases and provides comprehensive feedback and recommendations for product or design changes.