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Merck · 1 day ago

Senior Scientist/Engineer, Medical Device and Combination Products, Analytical

Lansdale, PA

Full-time

Hybrid

Mid, Senior Level

$117K/yr - $184K/yr

Merck is a leading global healthcare company dedicated to improving health and well-being through innovative solutions. They are seeking a Senior Scientist/Engineer to contribute to the development and commercialization of medical devices and combination products, focusing on analytical and material sciences. The role involves defining impactful scientific approaches, collaborating on cross-functional teams, and innovating analytical methods to enhance product performance.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Define and deliver impactful science to our MDCP portfolio programs in both late-stage development and commercial manufacturing in the context of characterization, design verification, technical risk assessment, changes, and investigations

Represent the CPDA on cross functional teams effectively as a trusted collaborator, clear communicator (verbal and written) and analytical technical leader, who asks critical questions to help define direction and takes actions to deliver

Innovate and improve our analytical approaches to interrogate critical functionality, geometry and function and failure modes relevant to manufacturing, packaging, distribution or patient/provider use

Deliver sharp problem solving through theoretical & experimental acumen [breadth and depth] and creative thinking

Recognize technology gaps and drive to industry-leading fundamental understanding, as needed, in the realm of engineered materials, component/device designs, and function through depth in areas such as tribology, solid-mechanics, advanced material science, mechanical simulation and human factor studies

Broaden and deepen your technical proficiency through learning and collaboration within the full CPDA, which includes primary packaging & protective packaging technology responsibilities, and our embedded sister group, which is a comprehensive physical materials science laboratory supporting (bio)pharmaceutical drug product commercialization and manufacturing

Qualification

Analytical Method DevelopmentMedical Devices DesignDevice CharacterizationMechanical TestingMaterials EngineeringDesign VerificationChemical SynthesisChromatographyFlow CytometryMass SpectrometryPackaging EngineeringPlastics EngineeringPolymers TechnologyProcess Analytical TechnologyProtein ChromatographySpectroscopySynthetic Biology

Required

Ph.D. in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Materials Science & Engineering, or closely related field

Demonstrated record of experimental research and publication in peer-reviewed journal(s)

Proficiency with applied mechanical testing and material imaging

Medical device development with practical understanding of Design Controls (21 CFR 820.30) and relevant industry standards

Proficiency in Device Characterization, for functionality and robustness

Design Verification strategy & execution with respect to selection, development & validation of methods as well as principled design of stability studies, acceptance criteria and protocols

Successful interdisciplinary research or manufacturing team projects

Research involving solid mechanics or tribology, engineering/ processing of polymers, ceramics or glass, advanced material science, or mechanical simulation

Analytical Method Development

Chemical Synthesis

Chromatography

Flow Cytometry

Mass Spectrometry Based Proteomics

Materials Engineering

Medical Devices

Medical Devices Design

Packaging

Packaging Engineering

Packaging Processes

Plastics Engineering