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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Manufacturing Engineer 2-2

Manufacturing EngineeringConfirmed live in the last 24 hours
Full-timeAlden, NY, USAIn-person

About the Job

Requirements

  • A bachelor's degree in an engineering or related technical field and at least three years of relevant experience; candidates who do not meet the education requirement may be considered with 7 or more years of relevant experience.
  • Ability to work independently and collaboratively with associates and cross-functional teams.
  • Solid technical aptitude and the ability to contribute to a team or produce technical results individually.
  • Functional understanding of Integer Quality Management Systems and ability to complete required Quality System documentation tasks with little or no direction.
  • Competency in written and oral communication.
  • Ability to maintain a calm demeanor in a high-energy, constantly changing production environment.

Responsibilities

  • Support ongoing production operations and serve as the primary technical support resource for production lines, working with production associates daily to support processes and equipment and resolve technical issues.
  • Develop, detail, and implement process and equipment solutions that improve safety, quality, delivery, and cost on existing production lines.
  • Develop and procure tooling, fixtures, and manufacturing equipment that optimize productivity, maintainability, and cost.
  • Create and maintain manufacturing documents and digital operations systems, including engineering drawings, bills of materials, routers, process work instructions, engineering change orders, and manufacturing execution system configuration modeling.
  • Lead equipment qualification and process validation tasks.
  • Collaborate with cross-functional teams to evaluate and influence designs for manufacturability, cost reduction, and business growth projects.
  • Work with manufacturing, quality, and supply chain associates to identify process improvement opportunities and evaluate or disposition non-conforming products as needed.
  • Establish and execute corrective and preventive action plans to remediate system quality or operational concerns and proactively mitigate potential production-operation failures.
  • Participate in cross-functional project teams to implement solutions.
  • Adhere to company values and safety, environmental, security, quality, U.S. Food and Drug Administration, company policy, operating procedure, and other regulatory requirements.
  • Work independently with occasional guidance to evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment to make minor adaptations and modifications to existing specifications, procedures, and work instructions.
  • Review procedures and plans before implementation and evaluate existing products, processes, and materials for failure analysis and potential improvements.
  • Participate in projects to investigate, develop, document, and implement new product and process technologies of moderate complexity and scope.
  • Respond to issues raised by others while proactively identifying technical challenges, mitigating potential issues, and incorporating improvements.
  • Plan, schedule, and execute engineering work within part of a major project or lead a smaller-scope project.
  • Use standard quality management and production system methodologies on technical projects to investigate product and process improvement opportunities.
  • Apply standard data-analysis practices and techniques to establish root causes of product and process failures or support improvement justifications.
  • Observe products and processes, recognize result discrepancies, and follow operations through detailed steps to establish their root causes.
  • Collaborate and exchange information with others, ask questions, and regularly check for understanding to support development as an engineer.
  • Assure adherence to the Quality Management System, facilitate or contribute to corrective and preventive actions, and contribute to quality key performance indicators and the journey to 5 Sigma.
  • Perform other duties as needed and directed by line supervision.
  • Support Manufacturing Excellence and Market Focused Innovation strategies by championing development and deployment of systems and tools that drive innovation and continuous improvement.
  • Embrace the Manufacturing Excellence culture based on the Integer Production System through strategy alignment with site Hoshin plans, Sales, Inventory, and Operations Planning meetings, and value stream map updates.
  • Support sustained change through production monitoring and improvement activities and deployment of Leader Standard Work.
  • Support standardization through workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs.
  • Promote associate engagement through standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
  • Support systems and process optimization through built-in quality, optimized scheduling and material system designs, work-cell design, and total productive maintenance.
  • Actively support Environmental Health and Safety programs.
  • Achieve site quality key performance indicators and defined goals, objectives, project milestones, and expectations.
  • Identify ways to shorten project durations and improve efficiencies by changing current processes and procedures.
  • Generate continuous-improvement suggestions and support their implementation.

About the Company

Integer Holdings Corporation

Medical device CDMO for cardiac devices

Integer Holdings Corporation is a large medical device CDMO that serves cardiac rhythm management, neuromodulation, and cardiovascular markets. It designs, develops, and manufactures device components and subassemblies through its brands Greatbatch Medical, Lake Region Medical, and Electrochem. The company differentiates itself by its scale, broad capabilities across multiple medical specialties, established brands, and global manufacturing footprint, enabling reliable supply for device makers. Its goal is to help medical device companies bring safe, effective technologies to market and improve patients’ lives worldwide.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Wilmington, DE
Founded
1940

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