Mechanical Engineer - Medical Devices (CAD/FEA)

RXinsider LTD.; Durham, Northern (NC, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

BD is seeking a Mechanical Engineer to contribute to the design, development, and testing of pharma equipment, applying engineering principles to solve complex problems and ensure regulatory compliance.

The role requires 5+ years in mechanical engineering, SolidWorks proficiency, and experience with design control (ISO 13485, FDA QSR). Collaboration across disciplines and rigorous documentation are essential for success in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical Engineering (or related field).
• 5+ years of experience in mechanical engineering, preferably in medical device or regulated industry.
• Proficiency in 3D CAD software (e.g., SolidWorks).
• Experience with FEA software and principles.
• Strong understanding of mechanical design, materials, and manufacturing processes.
• Demonstrated ability to apply problem-solving techniques to complex engineering challenges.
• Excellent written and verbal communication skills for cross-functional teams.
• Experience with design control and quality system requirements (e.g., ISO 13485, FDA QSR) is a plus.
• Ability to work independently and in a team in a fast-paced environment.
• Experience with prototyping and testing methodologies.

Responsibilities

• Design, develop, and test mechanical components and systems for pharma equipment.
• Conduct mechanical analysis (stress, strain, thermal) to optimize designs.
• Collaborate with electrical, software, and manufacturing teams throughout product lifecycle.
• Develop and execute test plans; analyze data and prepare reports.
• Participate in design reviews, FMEA, and risk assessments.
• Support manufacturing transfer activities including fixture design and process development.
• Adhere to quality system regulations and company procedures.
• Generate and maintain engineering drawings, specifications, and DHFs.
• Stay current with industry trends and best practices.

Skills

CAD design

FEA

Mechanical design

Prototyping

Analytical skills

Written communication

Verbal communication

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

FEA software

Job description

BD is seeking a Mechanical Engineer to contribute to the design, development, and testing of pharma equipment, applying engineering principles to solve complex problems and ensure regulatory compliance.

The role requires 5+ years in mechanical engineering, SolidWorks proficiency, and experience with design control (ISO 13485, FDA QSR). Collaboration across disciplines and rigorous documentation are essential for success in a fast-paced environment.