Medical Device Mechanical Engineer - Prototyping & Testing

Actalent, Inc.; Mahwah (NJ); On-site; USD 69,000 - 83,000; Full time

Benefits offered by this job

2 weeks PTO

6 paid holidays

Job summary

Actalent, Inc. in Mahwah, NJ seeks a Mechanical Engineer to design, prototype, and test medical devices. The role emphasizes hands-on prototyping, Creo CAD work, and rigorous validation to meet ISO/FDA standards.

You will collaborate with R&D, manufacturing, and QA to refine designs, perform mechanical testing, and document results. This contract onsite role offers a collaborative environment for rapid prototyping and regulatory compliance.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of experience in mechanical engineering, preferably in medical devices.
• Proficiency in Creo CAD software.
• ASME Y14.5 or ISO drafting proficiency.
• Strong understanding of mechanical testing methods and equipment.
• Ability to work effectively in a team and communicate clearly with cross-functional teams.
• Knowledge of ISO/FDA regulatory standards is a plus.
• Experience with rapid prototyping (3D printing, CNC) and mechanical testing equipment.

Responsibilities

• Design, develop, and test prototypes of medical devices.
• Determine when hand calculations are sufficient vs simulations.
• Execute engineering analyses.
• Perform tolerance analysis.
• Conduct mechanical testing and analysis to validate designs.
• Collaborate with R&D, manufacturing, and QA to refine prototypes and ensure manufacturability.
• Develop and execute test plans, protocols, and reports.
• Utilize CAD to create design drawings and specs.
• Perform root cause analysis and implement corrective actions.
• Stay current with industry standards and regulatory requirements for medical devices.
• Document all testing activities per company policies and regulatory guidelines.

Skills

Hands-on prototyping

Problem-solving

Team collaboration

Regulatory knowledge

Education

Bachelor's degree in Mechanical Engineering

Tools

Creo CAD

ASME Y14.5 / ISO drafting

Job description

Actalent, Inc. in Mahwah, NJ seeks a Mechanical Engineer to design, prototype, and test medical devices. The role emphasizes hands-on prototyping, Creo CAD work, and rigorous validation to meet ISO/FDA standards.

You will collaborate with R&D, manufacturing, and QA to refine designs, perform mechanical testing, and document results. This contract onsite role offers a collaborative environment for rapid prototyping and regulatory compliance.