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 Cadwells 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 Cadwells 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 Cadwells 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 Cadwells production environment robust efficient and scalable
• Ensures processes and systems align with applicable regulations (FDA 21 CFR Part 820 ISO/745/EU Medical Device Regulation); supports internal and external audits from FDA and Notified Bodies
• Supports the development and continuous improvement of Cadwells 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:

• Bachelors degree in engineering or equivalent experience
• Typically has greater than two (2) years of relevant professional or technical engineering experience
• Typically has experience manufacturing regulated equipment. Ideally this experience is in a medical or similar safety-conscious highly regulated industry

Physical Requirements and Working Conditions:

• Positions working with Cadwell equipment generally may require some reaching bending stooping squatting crawling kneeling pushing pulling lifting and carrying up to 50 pounds finger dexterity repetitive motions standing walking sitting hearing visual acuity color vision and 2-way written/verbal communication. More specific details may be provided as needed or requested
• Extensive use of a computer will be required
• Travel may be required; must be able to obtain necessary travel documents
• Work hours outside normal business hours may be required at times to meet business needs

Cadwell Industries Inc. is an Equal Opportunity Employer and as such affirms the right of every person to participate in all aspects of employment without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position contact our Human Resources department at