Senior Mechanical Engineer – Diagnostics & Manufacturing

Arcmed; Boonton (NJ); On-site; USD 85,000 - 125,000; Full time

Job summary

Arcmed in New Jersey is seeking a mid-level Mechanical Engineer to bridge R&D and production in a fast-paced CDMO. You will own design transfers, optimize manufacturing performance, and contribute to new product development, working on diagnostic sub-assemblies and modules.

The role requires 5–8 years in regulated environments, SolidWorks proficiency, GD&T, and V&V planning. You will collaborate cross-functionally, implement automation, and maintain DHF under ISO 9001 while interfacing with

Qualifications

• Bachelor's degree in mechanical engineering or related technical discipline.
• 5–8 years of progressive engineering experience in a regulated environment.
• Proficiency in SolidWorks for component and assembly design.
• Strong GD&T expertise including complex tolerance analysis.
• Solid understanding of ISO 9001, design controls, and maintaining DHF.
• Experience managing engineering changes via ECO/ECN workflows.
• Proven RCA and CAPA leadership.
• Experience developing and executing V&V plans.
• Ability to optimize engineering and manufacturing processes.
• Strong communication skills for technical presentations.

Responsibilities

• Lead design and development of complex diagnostic sub-assemblies and modules from concept through verification and design transfer.
• Design diagnostic sub-assemblies and modules using SolidWorks through design transfer.
• Apply GD&T and tolerance analyses to ensure high-yield manufacturing and proper fit.
• Perform structural, thermal, fluidic and FEA analyses with prototyping where needed.
• Own engineering decisions balancing performance, cost, manufacturability and quality.
• Implement automation and continuous improvement to increase throughput and reduce costs.
• Support production lines by troubleshooting and improving line efficiency.
• Lead RCA and implement robust CAPA and ECO/ECN workflows.
• Develop and execute V&V plans for fluidic and electromechanical systems.
• Maintain DHF and ISO 9001 compliance; interface with customers and suppliers.

Skills

Design transfer

SolidWorks

GD&T

V&V planning

RCA / CAPA

Automation

Manufacturing scale-up

ISO 9001

Cross-functional collaboration

Education

Bachelor's degree in mechanical engineering

Master's degree (preferred)

Tools

SolidWorks

Epicor

Job description

Arcmed in New Jersey is seeking a mid-level Mechanical Engineer to bridge R&D and production in a fast-paced CDMO. You will own design transfers, optimize manufacturing performance, and contribute to new product development, working on diagnostic sub-assemblies and modules.

The role requires 5–8 years in regulated environments, SolidWorks proficiency, GD&T, and V&V planning. You will collaborate cross-functionally, implement automation, and maintain DHF under ISO 9001 while interfacing with