Mechanical Engineer

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 is a leader in designing, developing, and manufacturing advanced x-ray systems within the USA. With two primary focus areas, our product line consists of standard and custom high-frequency x-ray generators in fully integrated or modular enclosures and complete medical x-ray systems.

We have a passion for innovation and a commitment to excellence. Within our 15,000 square foot ISO/MDSAP 13485 and FDA Registered facility, we take pride in ensuring our products are crafted to the highest quality standards. Our team continuously works to improve our systems and services to achieve this goal.

We have an exciting opportunity available for a dynamic and self-driven individual to join our mechanical engineering team.

Job Description

• Develop, coordinate, and monitor all aspects of mechanical engineering designs following company internal quality assurance procedures and forms
• Develop risk management plans, design dossiers, 2D & 3D models, drawings and schematics
• Manage ECN, work instructions and prototype processes
• Internally work cross-functionally with different departments and collaborate with outside organizations as necessary
• Work effectively in and maximize the use of our ERP system by generating part numbers with associated specifications, bill of materials, and assemblies
• Work effectively with certification bodies and assist in the completion of TRFs
• Follow all Source-Ray, Inc., procedures and OSHA workplace requirements
• Associate degree or bachelor’s degree in mechanical engineering
• 3+ years of experience
• Self-motivated with a positive attitude and ability to work in a team environment
• Excellent organizational skills, such as time and product design management
• CADD software (SolidWorks)
• Strong computer skills; Expertise in all Microsoft Office Suite products
• Risk management based on ISO 14971, (FEA, FMEA)
• Knowledge of IEC standards (60601-1, 60601-1-2, 60601-2-28, etc.)
• Basic knowledge of ISO 13485/MDSAP, 21CFR standards and regulations
• Familiarity with x-ray technology
• Machining experience highly desirable
• Clear and concise writing style
• Experience working with an ERP system
• Familiarity with IEC 62366 preferable
• 401(k) with matching
• Health insurance
• Paid time off
• Long Term Disability
• Referral program

$70,000.00 - $115,000.00 per year

This job description is not all inclusive and is subject to change at any time. Source-Ray, Inc., provides equal employment opportunity to all individuals regardless of their race, color, religion, gender, national origin, creed, age, sexual orientation, disability, veteran status, or any other characteristic protected by state, federal, or local law. The company takes affirmative action to ensure that applicants and employees are treated during the application process and post hiring employment without regard to any of these characteristics. Discrimination of any type is not tolerated.