Lead Validation Engineer

American Axle & Manufacturing-AAM

is seeking an experienced Lead Validation Engineer to join our dynamic and innovative team. Reporting to the Manager of Validation Engineering, the Lead Validation Engineer will be responsible for leading the validation process for new and existing products, ensuring that all engineering processes are compliant with all applicable regulations and requirements. The ideal candidate for this position will possess a minimum of a Bachelor's degree in Mechanical Engineering or a related discipline, along with a minimum of five years of experience in a validation engineering role. The successful candidate will have a strong background in developing and executing validation plans, as well as a solid understanding of design controls, risk management, and medical device regulations. In addition to technical knowledge, the Lead Validation Engineer must possess excellent communication, organization, and problem-solving skills in order to assist in the achievement of the company’s goals. At AAM, we are passionate about creating an atmosphere of collaboration, innovation, and growth. If you possess the qualifications and experience we are looking for, and are ready to take the next step in your career, we invite you to apply!

Responsibilities:

• Lead the validation process for new and existing products, ensuring compliance with all applicable regulations and requirements.
• Develop and execute validation plans.
• Monitor the progress of validation activities.
• Collaborate with other departments to identify and address potential risks.
• Develop and maintain design control documentation.
• Ensure risk management processes are followed.
• Maintain knowledge of applicable medical device regulations.
• Utilize problem-solving skills to address technical issues.
• Provide reports and updates to the Manager of Validation Engineering.
• Ensure that all validation activities are completed in a timely and efficient manner.

Equal Opportunity Employer

American Axle & Manufacturing-AAM is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.