Easter Seals Jobs

Role: Manufacturing EngineerLocation: Ponce, Puerto RicoJob Description •Develop and execute IQ, OQ, and PQ protocols for process validation and equipment qualification.•Utilize Design of Experiments (DOE) to optimize manufacturing processes and ensure repeatability.•Perform root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.•Collaborate with cross-functional teams to manage Non-Conformance Reports (NCR) and ensure timely resolution.•Apply Statistical Process Control (SPC) and other statistical tools like Minitab to monitor and improve manufacturing processes.•Design and develop fixtures and tooling to support production and validation activities.•Lead or support automation projects to enhance process efficiency and reliability.•Work within Agile frameworks to manage tasks and contribute to continuous improvement initiatives.•Ensure compliance with regulatory standards and internal quality systems specific to medical device manufacturing.Preferred Qualifications:•Bachelor’s degree in Engineering or a related field.•3-5+ years of experience in manufacturing engineering, preferably in the medical device industry.•Proficiency in process validation and validation documentation, including IQ, OQ, and PQ.•Strong knowledge of DOE, SPC, and Minitab for statistical analysis.•Experience with CAPA, NCR, and quality management systems.•Familiarity with fixture design, manufacturing automation, and process optimization.•Working knowledge of Agile methodologies is preferred.