Mechanical Engineer

Pacer Group; Rahway (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a dedicated Scientist to join their Device Development & Technology Team. This role focuses on the characterization and testing of innovative drug delivery devices, ensuring they meet rigorous standards through analytical engineering and method development. The ideal candidate will possess exceptional mechanical testing skills, a strong background in 3D CAD, and the ability to work collaboratively in a fast-paced lab environment. This is a fantastic opportunity to contribute to cutting-edge projects that aim to improve patient outcomes and drive advancements in medical technology.

Qualifications

• Experience in mechanical testing and method development.
• Fluency with imaging and measurement equipment.
• Experience in medical device development and design controls.

Responsibilities

• Characterization and testing of drug delivery devices.
• Technical interrogation of device platforms for improvements.
• Utilize analytical methods to understand device properties.

Skills

Mechanical Testing

Test Method Development

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)

Job description

Direct message the job poster from Pacer Group

Director-Client Services, Delivery and Operations

Job Title: Scientist // Mechanical Testing

Duration: 12 Months

Location: Rahway, NJ 07065

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, rheometric, 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, 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.
• Developing innovative mechanical tests with validations, including engineering studies, design verification protocols, stability studies, and validation protocols. Ensuring appropriate measurement system analysis (MSA) for all finished product performance test methods during tech transfer or lifecycle.
• Experience with medical device development with understanding of Design Controls (21 CFR 820.30).
• Familiarity with standards such as ISO 13485, ISO 14971, EU MDR, EN 60601, IEC 62304, ISO 11608.
• Additional knowledge in industry-related areas like 21 CFR Part 4, 21 CFR 211, FDA guidance on container closure systems, ISO standards, etc.

Responsibilities:

• The Device Development & Technology (DD&T) Team seeks a hands-on/ lab-focused Scientist for characterization and testing of devices (components, sub-assemblies, full devices) and combination products (drug-delivery).
• Responsible for technical interrogation of drug delivery device platforms to identify risks and opportunities for improvement.
• Utilize analytical instruments, methods, and data analysis to understand device material and functional properties.
• Evaluate devices like injector pens, on-body injectors, inhalers, often with limited material at early stages, demanding creative approaches.

Comments/Special Instructions:

• Must haves: Analytical engineering, familiarity with test methods, method development, and validation.