Manufacturing/Engineer II

Overview: This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment. Responsibilities: Scope � Consultant/ Department expert � Technical Expertise � Organizational credibility and knowledge � Guides and Develops Others � Influences and directs others within Department � Results Oriented � Project Leader � Business Knowledge Potential Task Assignments within the scope of this position 1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation 2. Maintains a professional working relationship with internal & external customer and support staff 3. Participates and/or leads cross-functional teams. 4. Provides technical support on components, material methods, systems and equipment. 5. Develops physical and functional test requirements to assure specifications & regulations are met. 6. Writes and approves protocols, reports and data. 7. Oversees testing outlined in protocols and test methods 8. Coordinates/develops validation studies on equipment & processes 9. Executes design controls 10. Analyzes design inputs 11. Conducts complaints investigations 12. Understands and follows company procedures and regulatory requirements. 13. Participates in and provides input to training on department & division procedures, and policies. 14. Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking. 15. Plans and coordinates engineering test builds. 16. Analyzes problems in design, process and test development. Recommend solutions. 17. Prepares and presents oral and written project updates and technical discussions. 18. Develops and implements procedures to provide easy-to-follow instructions. Manufacturing Focus Responsible for the development, implementation and continuous improvement of processes and equipment to produce products which meets customer requirements and are cost effective. Qualifications: This position requires: � an Associate technical degree with 8 (eight) years of engineering experience within the medical device or equivalent regulated industry OR � a Bachelor degree in science or engineering with 4 (four) year of engineering experience within the medical device or equivalent regulated industry OR � Masters degree with 3 (three) years of engineering experience within the medical device or equivalent regulated industry OR � Demonstrated knowledge of engineering principles through 15 (fifteen) plus years of engineering experience within the medical device or equivalent regulated industry The above experience must include demonstrated effective project management skills. The incumbent must demonstrate the ability to perform the essential functions of the job as outlined in the duties and responsibilities. 20% to 25% travel required Multilingual ability - spanish/english preferred.