Sr. Manufacturing Engineer

PURPOSE OF JOB: 

• Lead transfer activities for new products and processes to meet corporate growth objectives.
• Develop process capabilities and production capacity to provide readiness to scale for commercial launch. 
• Provide manufacturing support for existing products and processes to meet company goals.

RESPONSIBILITIES: 

• Design and develop manufacturing processes for new and existing products, product changes, and related tooling and fixture modifications.  
• Provides line support, trouble-shooting, and coordinating repair of equipment.
• Perform or guide validations on equipment and processes (IQ/OQ/PQ) as well as creating test protocols in collaboration with Quality and preparing reports.
• Prepare document change orders and coordinates implementation of changes, including training operation team members.
• Improve manufacturing process instructions and lot history records, line flow, assembly methods, and product quality; assure manufacturing processes and related documentation follow established policies and procedures.
• Ensure reliability and performance of process equipment to deliver product to desired specifications.
• Lead pilot/engineering build activities for product or process enhancements.
• Work cross-functionally with product development to ensure products are developed with considerations for manufacturability and scalability for volume manufacturing.
• Creates and modifies component, assembly, or fixture drawings using SolidWorks.
• Completes accurate and timely manufacturing documentation including manufacturing procedures, materials records, validations, test reports, etc. 
• Support company goals and objectives, policies and procedures while adhering to Good Manufacturing Practices, quality system requirements, and FDA regulations.

PREFERRED EDUCATION: 

• Bachelor of Science or technical degree in Engineering (or equivalent experience) required.  Advanced degrees (Master of Science or MBA) desired.

PREFERRED EXPERIENCE: 

• Minimum of 5 years of experience in Medical Device industry; catheter-based experience a must.

ADDITIONAL SKILLS: 

• Effective communication, cross-functional team, interpersonal, and time management skills required.
• Proficiency with MS Office, SolidWorks, Project Management, and Minitab applications preferred.