Mechanical Engineer – Medical X-ray Systems & ISO 13485

Source-Ray, Inc.; New York (NY); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

401(k) with matching

Health insurance

Paid time off

Long Term Disability

Referral program

Job summary

Source-Ray, Inc. is seeking a dynamic Mechanical Engineer to develop and manage mechanical designs and risk assessments in a quality-focused environment. You will work with SolidWorks, ERP systems, and cross-functional teams to deliver assemblies and documentation.

The role requires a degree in mechanical engineering and at least 3 years of experience, with preferred familiarity with ISO 14971, IEC 60601 standards, and machining. Competitive benefits are offered in a US-based facility.

Qualifications

• Associate or bachelor’s degree in mechanical engineering is required.
• Minimum 3+ years of mechanical engineering experience.
• Solid experience with CADD/3D modeling (SolidWorks) and MS Office.
• Familiarity with x-ray technology and ISO 14971 risk management.
• Knowledge of IEC 60601-series standards and ISO 13485/MDSAP is preferred.
• Machining experience is highly desirable.

Responsibilities

• Develop, coordinate, and monitor mechanical engineering designs per QA procedures.
• Create risk management plans, design dossiers, 2D/3D models, drawings, and schematics.
• Manage ECN, work instructions, and prototype processes.
• Collaborate cross-functionally and with external organizations as needed.
• Utilize ERP to generate part numbers, specifications, BOMs, and assemblies.
• Assist in TRFs with certification bodies and follow OSHA requirements.

Skills

Self-motivated

Team collaboration

Organizational skills

Clear writing style

Strong computer skills

Experience with ERP systems

Familiarity with IEC standards

Education

Associate degree or bachelor’s degree in mechanical engineering

Tools

SolidWorks

Microsoft Office Suite

ERP systems

Job description

Source-Ray, Inc. is seeking a dynamic Mechanical Engineer to develop and manage mechanical designs and risk assessments in a quality-focused environment. You will work with SolidWorks, ERP systems, and cross-functional teams to deliver assemblies and documentation.

The role requires a degree in mechanical engineering and at least 3 years of experience, with preferred familiarity with ISO 14971, IEC 60601 standards, and machining. Competitive benefits are offered in a US-based facility.