The primary purpose of this position is to provide hands-on Manufacturing Engineering support for Operations and to interact with customers and provide support for quality systems engineering and process engineering.
Accountabilities & Responsibilities:
Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Responsible for identifying, tracking, resolving, and communicating major new product ramps and cost reduction initiatives at a facility
Leads the development and implementation of Quality and Regulatory requirements including Integer policies, procedures, and appropriate regulatory requirements
Plans, Develops, and ensures resources are adequate to execute Process and Test Method Validations (IQ, OQ, PQ, PPQ) in accordance with Integer procedures and guidelines
Communicates procedures, policies, improvement ideas, technical information, and recommendations clearly, effectively and frequently (oral and written) within Integer, with outside suppliers or partners and with Integer customers during formal and informal interactions
Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common Integer engineering tools & templates were available. (Examples include specifications, manufacturing procedures, ECOs, and technical reports or analysis)
Using Lean Leadership experience, applies and Promotes Lean manufacturing techniques to continuously improve cycle times and process flows. Identifies and directs the execution of improvement efforts to reduce waste in all manufacturing and business processes
Uses structured problem solving techniques and statistical methods for data driven analysis and decisions.
Using Black Belt experiences, leads DMAIC - Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes
Plans, executes and manages project activities with cross functional teams including finance, human resources, operations, quality and sales. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives, quality improvements and sales opportunities
Demonstrates leadership through mentoring of junior staff, responsiveness to business needs and motivation of diverse, cross functional teams including influencing both internal and external members to achieve positive business results
Leads staff performance management activities to improve capabilities and skills using regular objective setting and review process, performance appraisals and coaching of individual development plans
Demonstrates technical ability through the application of engineering skills, approaches and knowledge Performs other duties as required.
Education & Experience:
Minimum Education: Bachelor of Science in Engineering/Technical field, advance degree Master
Minimum Experience: 10+ years of experience (5+ in medical device industry)
Knowledge & Skills:
Special Skills: Strong leadership skills. Ability to multi-task and prioritize projects.
Specialized Knowledge: Six Sigma Black Belt certification preferred. Knowledge of ISO and regulatory standards is a must.