Associate Principal Scientist, Device Product and Process Development (Associate Director Equiv[...] - Rahway New Jersey

Company: Merck
Location: Rahway, New Jersey
Posted On: 05/06/2025

Job DescriptionOur Company's Device Product and Process Development (DPPD) Team is seeking a hands-on device characterization and design focused scientist.This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. They will utilize a wide variety of cutting-edge analytical instruments and methods, including in silico modeling, to build fundamental understanding of the devices' material and functional properties and attributes. This understanding, combined with extensive data analysis/interpretation, will allow the role to design and develop functional improvements for these platforms and, as the opportunities arise, develop new and novel delivery technologies.These drug delivery device technology platforms are often assemblages of glass pre-filled syringes, injection molded plastic components driving delivery of a drug, typically though mechanical or electro-mechanical means. Examples include, but not limited to, injector pens and inhalers.Education Requirement (minimum):

• Ph.D. in Mechanical Engineering or equivalent field is required.Required Experience and Skills:
  • A minimum of a Ph.D. plus 4 years of device design and engineering evaluation experience.
  • Fluency in structural finite element analysis (FEA).
  • Solid testing and troubleshooting skills able to work independently in a laboratory setting.
  • Experience with mechanical testing, imaging, and measurement equipment and techniques, including, but not limited to, mechanical testing, surface characterization, x-ray computed tomography, rheometry, and microscopy.
  • Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
  • Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
  • Cross-functional communication - communicating complex mechanical engineering information in layman's terms to facilitate cross-functional understanding and to support project timelines.
  • Development experience in risk-oriented, regulated environments.
  • Development project leadership with a proven track record collaborating with and managing external vendors/research partners.Preferred Experience and Skills:
    • 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, ISO 11608 Needle-based injection system for medical use.
    • Familiarity with Design Verification (DV) strategies and 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.
    • Additional familiarity/experience with the following 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 10993US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.Employee Status:RegularRelocation:DomesticVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:HybridJob Posting End Date:04/18/2025Requisition ID:R327772
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