Assistant Scientist

Spectraforce Technologies; Rahway (NJ); On-site; USD 60,000 - 100,000; 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 devices and combination products, utilizing a variety of analytical instruments and methods. The ideal candidate will have a strong background in mechanical testing and troubleshooting, with the ability to work independently in a laboratory environment. This position offers the opportunity to contribute to cutting-edge projects in the medical device sector, ensuring compliance with industry standards and enhancing product development processes. If you are passionate about engineering and eager to make a significant impact, this role is for you.

Qualifications

• Experience in design, engineering, and mechanical testing/test method development.
• Fluency with mechanical testing, imaging, and measurement equipment.
• Ability to document and analyze test cases comprehensively.

Responsibilities

• Characterization and testing of devices and combination products.
• Utilize analytical instruments and extensive data analysis.
• Work with drug delivery device platforms and injection molded components.

Skills

Mechanical Testing

Troubleshooting Skills

3D CAD (SolidWorks)

Data Analysis

Collaboration Skills

Education

B.S. in Mechanical Engineering

M.S. in Mechanical Engineering

Ph.D. in Mechanical Engineering

Tools

Instron

Microscopes

Vision Systems (Keyence/Cognex)

Rheometry

Job description

Title: Scientist - I (Assistant)

Duration: 12 Months

Location: Rahway, NJ 07065

Qualifications

Education Requirement (minimum):

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

Required Experience and Skills

• A minimum of M.S., or B.S. plus 1-3 years of experience in design, engineering, and mechanical testing/test method development.
• Exceptional mechanical testing and troubleshooting skills, with the ability 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 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.
• Ability to document (following Good Documentation Practices) and analyze test cases, providing comprehensive feedback and recommendations for product or design changes.

Preferred Experience and Skills

• Experience operating and interpreting data from Instron, XRCT, Microscopes, Vision Systems (e.g., Keyence / Cognex), Bouncer, and drop shape analyzers.
• Development of innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols, ensuring appropriate measurement systems analysis (MSA).
• Experience with medical device development and an understanding of Design Controls (21 CFR 820.30).
• Familiarity with standards such as ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, and ISO 11608.
• Additional industry-related knowledge such as 21 CFR Part 4, 21 CFR 211, FDA guidance documents, and other ISO standards, is a plus.

Responsibilities

Scientist, Device and Combination Product Test

• The Device Development & Technology (DD&T) Team seeks a hands-on/lab-focused Scientist for characterization and testing of devices and combination products.
• Utilize a variety of analytical instruments, methods, and extensive data analysis to understand material and functional properties of devices.
• Work with drug delivery device platforms, often involving injection molded plastic components and mechanical or electro-mechanical means, requiring creative approaches due to limited initial material availability.