Validation Engineer II (Medical Industry)

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. BEPC Inc. is seeking a Validation Engineer II to join our fast-growing team of consultants in the Ciudad Juárez area. This role provides advanced technical engineering support to clients in the medical industry, focusing on validation and verification activities related to medical devices and equipment. The ideal candidate will have experience working with regulatory agencies such as FDA and ISO 13485, and be familiar with industry standards and guidelines for medical device development and testing. Key responsibilities include: • Developing and executing test plans and procedures for medical devices and equipment; • Conducting risk assessments and failure mode effects analysis (FMEA) to identify potential risks and failures in the design and manufacturing process; • Collaborating with cross-functional teams, including engineering, quality, and manufacturing to ensure compliance with regulatory requirements and industry standards; • Providing technical support and guidance to clients on validation and verification activities; • Staying up-to-date with industry trends, regulations, and best practices related to medical device development and testing. The successful candidate will have a strong background in mechanical or biomedical engineering, with experience working in the medical device industry. A bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field is required. • 3+ years of experience in validation and verification activities for medical devices and equipment; • Strong understanding of FDA regulations and ISO 13485 standards; • Experience working with CAD software and 3D modeling tools; • Excellent communication and interpersonal skills; • Ability to work independently and as part of a team; • Strong analytical and problem-solving skills. BEPC Inc. offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.