Scientist

LanceSoft Inc; Rahway (NJ); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a hands-on Scientist to join their Device Development & Technology Team. This role focuses on the characterization and testing of innovative drug delivery devices. The ideal candidate will have a strong mechanical testing background and experience in developing test methods. You will work with cutting-edge technology to identify risks and improve device functionality. If you are passionate about engineering and want to contribute to groundbreaking medical solutions, this is the perfect opportunity for you.

Qualifications

• Minimum of M.S. or B.S. plus 1-3 years of design and mechanical testing experience.
• Exceptional mechanical testing and troubleshooting skills in a lab setting.
• Fluency with mechanical testing and measurement techniques.

Responsibilities

• Characterize and test drug delivery devices and combination products.
• Utilize analytical instruments for data analysis and interpretation.
• Document test cases and provide recommendations for design changes.

Skills

Mechanical Testing

Troubleshooting

Data Analysis

3D CAD (SolidWorks)

Prototyping Skills

Test Method Development

Collaboration Skills

Education

B.S. in Mechanical Engineering

M.S. in Mechanical Engineering

Ph.D. in Mechanical Engineering

Tools

Instron

XRCT

Microscopes

Vision Systems (Keyence/Cognex)

Job description

Title: Scientist - Device and Combination Product Test
Location: Rahway, NJ
Contract Duration: 12 Months
Pay Range: $40.00 - $53.00 USD hourly on W2

Job Description:
• The 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 ***’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.

Quals--
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