Senior Mechanical Engineer – Medical Device Design & Testing

BD; North Carolina; On-site; 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 product quality and regulatory compliance.

The role requires a Bachelor’s in Mechanical Engineering and 5+ years in mechanical engineering (medical device preferred), with proficiency in SolidWorks and FEA. Expect cross-functional collaboration and on-site work with design control and testing responsibilities.

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 (SolidWorks) is required.
• Experience with FEA software and principles.
• Strong understanding of mechanical design, materials, and manufacturing processes.
• Proven ability to apply problem-solving techniques to complex engineering challenges.
• Excellent written and verbal communication skills for cross-functional collaboration.
• Experience with design control and quality system requirements (ISO 13485, FDA QSR) is a plus.
• Ability to work autonomously and in a fast-paced, dynamic environment.
• Experience with prototyping and testing methodologies.

Responsibilities

• Design, develop, and test mechanical components and systems for pharma equipment using CAD and FEA tools.
• Perform detailed mechanical analysis (stress/strain/thermal) to optimize designs for performance and manufacturability.
• Collaborate with electrical, software, and manufacturing teams across the product lifecycle.
• Develop and execute test plans, analyze data, and prepare reports to validate performance.
• Participate in design reviews, risk assessments, and FMEA to mitigate design flaws.
• Support manufacturing transfer activities including process development and fixture design.
• Adhere to quality system regulations and company procedures throughout development.
• Generate and maintain engineering drawings, specifications, and history files.
• Stay current with industry trends and best practices in mechanical engineering and medical device development.

Skills

SolidWorks

FEA

CAD

ISO 13485/FDA QSR

Communication skills

Prototyping & testing

Education

Bachelor's degree in Mechanical Engineering

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 product quality and regulatory compliance.

The role requires a Bachelor’s in Mechanical Engineering and 5+ years in mechanical engineering (medical device preferred), with proficiency in SolidWorks and FEA. Expect cross-functional collaboration and on-site work with design control and testing responsibilities.