Website On-Board Companies
On-Board Companies
Company : On-Board Companies
On-Board Scientific is hiring an Assistant Device Characterization Scientist in Rahway, NJ
For immediate consideration please send your resume to
Subject Line: Position Title and State you are located
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
Position Details:
Title: Assistant Device Characterization Scientist
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Rahway, NJ
Shift: 1st shift
Compensation: $38.25/HR
We are 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).
Responsibilities:
• This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting the 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, 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.
-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:
o 21 CFR Part 4
o 21 CFR 211
o FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics
o ISO 13485
o ISO 14971
o ISO 11040
o ISO 10993
Apply Today!
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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