Design Assurance Engineer

Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMOs) in the world, serving the cardio and vascular, neuromodulation, and cardiac rhythm management markets. As a strategic partner of choice, we advance the goals of our medical device customers through industry-leading engineering and manufacturing, with a relentless commitment to quality, service, and innovation. The company’s brands include Greatbatch Medical® and Lake Region Medical®.

The primary purpose of this job is to support new product development to ensure that the desired design performance is achieved meeting the applicable medical device FDA/European regulatory requirements and companies Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch.

• 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.
• Initiates, directs and manages the design, and development of new products and processes from concept to commercial manufacturing.
• Works closely with other departments to coordinate design engineering activities.
• Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.
• Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
• Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part o f a major project.
• Develops and /or reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials.
• Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications.
• Devises new approaches to problems encountered. Prepares all necessary paperwork and documentation for all projects undertaken.
• 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 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 programs, and improvement idea and suggestion systems.
• Systems & Process Optimization through adoption of principles of built in quality, optimized scheduling & material system designs, work cell design, and total productive maintenance.

How you will be measured:

• The specific measures listed below may be subject to change and are not intended to be an all-inclusive list
• Safety is our highest priority; you will be an active supporter of the Integer Environmental Health & Safety programs.
• Quality – Achievement of site Quality KPI’s
• You will have defined Goals and Objectives specifying key projects and expected milestones to achieve.
• Given your capabilities and experience, you will identify ways to shorten the project durations and make recommendations for systemic changes to current processes and procedures …