Job Description

Job Title: Mechanical Engineer (Scientist - II)

Job Location: Rahway, NJ

Job Duration : 12+ Months (Possibilities of Extension)

Job Description:

Scientist, Device and Combination Product Test

The Client Device Development & Technology (DD&T) Team is seeking a hands-on/ lab-focused Scientist 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 Client’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.

Qualifications:

Education Requirement (minimum):

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

Required Experience and Skills:

A minimum of M.S., or B.S. plus 1-3 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 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 analyze test cases and provide comprehensive feedback and recommendations for product or design changes.

Preferred Experience and Skills:

Experience operating and interpreting data from Instron, XRCT, MicroProducts, 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. Ensure 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

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