Manufacturing Engineer

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.At Integer, our values are embedded in everything we do.CustomerWe focus on our customers' successInnovationWe create better solutionsCollaborationWe create success togetherInclusionWe always interact with others respectfullyCandorWe are open and honest with one anotherIntegrityWe do the right things and do things right- Job Description Summary- Leads the introduction of a new product into manufacturing from either a product development or a customer stream by following a structured approach per Product/Process Development Process (PDP) or Manufacturing Transfer Procedure (MTP).Possesses leadership traits to effectively coordinate cross-functional activity.Has extensive experience in setting up products within ERP systems, leads the validation process per standards' requirements, for example, cGMP.Is knowledgeable of product type industry standards, is experienced in general manufacturing process development.Possesses project management skills to plan, execute and control as well as excellent communication skills to report status and to drive escalation of issues.Ensures the process capacity and scalability in collaboration with industrial/lean groups to ultimately meet the volume and quality requirements.- What you'll do in this role:- The primary purpose of this position is to perform work which involves general engineering methods and tools; but you may also utilize more advanced technologies and engineering concepts while you are developing in your role as an engineer in the medical device industry.In this role, you will ensure that Integer's internal and external customer expectations are met or exceeded_- with occasional direction, instruction and guidance from more experienced engineers and managers in your organization._- You adhere 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.-- You will review procedures and plans prior to implementation as well as evaluate existing products, processes and materials for failure analysis and potential improvements.- You will participate in projects that require you to investigate, develop, document and implement new product and process technologies of moderate complexity and scope.- While often you may be responding to situations presented to you by others, you will also be able to demonstrate proactive insight into technical challenges and mitigates potential issues or incorporates improvements.- You will plan, schedule and execute the engineering work in a part of a major project; or you may lead a smaller scope project.- You will perform work on technical projects where you will follow Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements.-- You will be required to observe products and processes to recognize discrepancies in results and follow operations throughout a series of detailed steps or processes to establish root cause of the discrepancies.- You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.- You embed Quality within the Engineering discipline - "I own Quality."You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), facilitating and/or contributing to corrective and preventive actions, and contributing to the successful attainment of our quality KPI's and journey to 5 Sigma.- You may perform other duties as needed and as directed by your line of supervision.- Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies_- You champion the development of and deployment of the systems and tools to drive innovation and continuous improvement.- You embrace the Manufacturing Excellence culture based on the Integer Production System and its five focus areas:- Strategy Alignment through Site Hoshin Plans, the regular cadence of Sales, Inventory, and Operations' Planning (SiOP) meetings, and regular updates to the value stream maps.- Leadership of Sustained Change by ensuring production monitoring & improvement activities and deployment of Leader Standard Work.- Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs.- Associate Engagement promoted through the adoption of standardized problem solving.methodologies, behavior-based safety