I

Integer Holdings Corporation

Medical device CDMO for cardiac devices

Manufacturing Engineer 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 are required; candidates who do not meet the education requirement may be considered with seven or more years of relevant experience.
  • Ability to work independently and collaboratively with associates and cross-functional teams.
  • Solid technical aptitude and 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.

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 equipment used in manufacturing to 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 address system quality or operational concerns and proactively mitigate potential production operations failures.
  • Participate in cross-functional project teams to implement solutions.
  • Adhere to Integer’s values and all safety, environmental, security, quality, company policy, operating procedure, U.S. Food and Drug Administration, and other regulatory requirements.
  • Generally work independently, using judgment to evaluate, select, and apply standard engineering techniques, procedures, and criteria and make minor adaptations 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.
  • Anticipate technical challenges, mitigate potential issues, and incorporate improvements.
  • Plan, schedule, and execute engineering work within 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 justifications for improvements.
  • Observe products and processes, recognize discrepancies in results, and follow operations through detailed process steps to establish root causes.
  • Collaborate with others, exchange information, ask questions, and check for understanding in support of engineering development.
  • 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 supervision.
  • Support Integer’s Manufacturing Excellence and Market Focused Innovation strategies by championing development and deployment of systems and tools for innovation and continuous improvement.
  • Embrace Manufacturing Excellence through strategy alignment using site Hoshin plans, regular Sales, Inventory, and Operations Planning meetings, and value stream map updates; sustained change through production monitoring, improvement activities, and Leader Standard Work; standardization through workplace organization and visual controls (5S), Manufacturing Standard Work, and training and certification programs; associate engagement through standardized problem-solving methods, behavior-based safety programs, and improvement idea systems; and systems and process optimization through built-in quality, optimized scheduling and material system designs, work cell design, and total productive maintenance.
  • Actively support Integer Environmental Health and Safety programs.
  • Achieve site quality key performance indicators and defined goals and objectives, including key projects and milestones.
  • Identify ways to shorten project durations and improve current processes and procedures to increase efficiency.
  • 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

Recently Posted Jobs

Explore more opportunities at Integer Holdings Corporation

See more jobs