Staff Mechanical Engineer, Durham, North Carolina

Job Responsibilities

• Design, develop, and test mechanical components and systems for pharma, utilizing CAD software (e.g., SolidWorks) and finite element analysis (FEA) tools.
• Conduct detailed mechanical analysis, including stress, strain, and thermal analysis, to optimize designs for performance, reliability, and manufacturability.
• Collaborate with cross-functional teams, including electrical engineers, software engineers, and manufacturing personnel, throughout the product development lifecycle.
• Develop and execute test plans, analyze test data, and prepare comprehensive reports to validate product performance and verify design specifications.
• Participate in design reviews, risk assessments, and failure mode and effects analysis (FMEA) to identify and mitigate potential design flaws.
• Support manufacturing transfer activities, including process development, fixture design, and troubleshooting production issues.
• Adhere to all relevant quality system regulations and company procedures throughout the product development process.
• Generate and maintain accurate engineering documentation, including drawings, specifications, and design history files.
• Stay current with industry trends, new technologies, and best practices in mechanical engineering and medical device development.

Job Qualifications

• Bachelor's degree in Mechanical Engineering or a related field.
• 10+ years of experience in mechanical engineering, preferably within the medical device or a highly regulated industry.
• Proficiency in 3D CAD software (e.g., SolidWorks) is required.
• Experience with FEA software and principles.
• Strong understanding of mechanical design principles, material science, and manufacturing processes.
• Demonstrated ability to apply problem-solving techniques to complex engineering challenges.
• Excellent written and verbal communication skills, with the ability to effectively collaborate with diverse teams.
• Experience with design control and quality system requirements (e.g., ISO 13485, FDA QSR) is a significant plus.
• Able to work independently and as part of a team in a fast-paced, dynamic environment.
• Experience with prototyping and testing methodologies.

About the Role

The Staff Mechanical Engineer will contribute to the design, development, and testing of pharma and related equipment, applying engineering principles to solve complex problems and ensure product quality and regulatory compliance.