Manufacturing Engineer

The Manufacturing Engineer develops, maintains, and continuously improves the manufacturing lines, equipment, processes, and training used on the production floor. As a hands-on owner of how manufacturing at Cadwell is done, this role ensures that production can reliably meet Cadwell’s business demands while manufacturing high quality products. The Manufacturing Engineer oversees and maintains process and equipment improvements, supports new product introductions, and partners with cross-functional teams to optimize production efficiency, quality, and consistency. Job Duties and Responsibilities: Creates, maintains, and continuously improves the manufacturing systems (processes, equipment, training, etc.) used to manufacture Cadwell’s medical devices, for both existing and new designs Specifies, develops, and maintains production line test methods, processes, and fixtures; ensures test approaches are repeatable, scalable, and support Cadwell’s business needs Troubleshoots production line issues to eliminate equipment and material as a source, and implements corrective and preventive actions on the production floor; escalates issues to engineering teams as necessary to Identifies, scopes, and justifies capital equipment needs for manufacturing investments Stays current with manufacturing industry practices and technologies to help keep Cadwell’s production environment robust, efficient, and scalable Ensures processes and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies Supports the development and continuous improvement of Cadwell’s equipment calibration program, executing in-house and outsourced calibration activities to ensure compliance and efficiency Partners with other departments such as R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day-to-day operation of the production environment Supports the Manufacturing Engineering team through the NPI and design transfer processes; helps ensure that designs and their manufacturing processes are robust and repeatable Perform other duties as assigned Qualifications: Knowledge, Skills, and Abilities: Working knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput and yield Working knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges Knowledge of and experience with change control processes and activities Knowledge of design-for-manufacture concepts and their practical application during the engineering development process Knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line setup, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria Familiarity with New Product Introduction (NPI) and the design lifecycle, with hands-on experience supporting programs from engineering development through manufacturing validation, production release, and ongoing manufacturing support of active designs Working knowledge of Continuous Improvement processes (i.e. Lean Manufacturing - Six Sigma, Kaizen, 5S, etc.) Familiarity with Automation and Technology Integration; exposure to practical applications of technologies and smart manufacturing integration to increase quality and reduce rework Ability to analyze data and situations, exercise sound judgment, plan and organize work, and communicate effectively across teams Ability to identify and communicate risk with appropriate urgency, helping keep manufacturing programs on schedule with consistent follow-through on execution Education / Experience: Bachelor’s degree in engineering or equivalent experience Typically has greater than two (2) years of relevant professional or technical engineering experience Typical…