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Integer Holdings Corporation

Medical device CDMO for cardiac devices

Process Development Engineer 1

Manufacturing EngineeringPosted on Nov 5
Full-timePlymouth, MN, USAIn-person

About the Job

Requirements

  • A bachelor's degree in an engineering or related technical field and 0–3 years of experience are required; candidates without the education requirement may be considered with 5 or more years of relevant experience.
  • Ability to work independently and collaboratively with associates and cross-functional teams.
  • Technical aptitude to contribute to a team or produce technical results individually.
  • Written and oral communication skills.
  • Ability to maintain a calm demeanor in a high-energy, constantly changing production environment.

Responsibilities

  • Develop processes and equipment to introduce new products into manufacturing sites, ensuring safe, high-quality, and cost-effective results.
  • Identify existing or develop new process and equipment technology, characterize and optimize processes, and validate processes and manufacturing lines.
  • Establish efficient production line layouts as part of a new product introduction team, or lead process improvements to existing plant operations.
  • Estimate production times, staffing requirements, and related costs as needed.
  • Adhere to company values and all safety, environmental, security, and quality requirements, including Quality Management Systems, Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration regulations, company policies, operating procedures, and other regulatory requirements.
  • Under the supervision of experienced engineering mentors and managers, select and apply standard engineering techniques, procedures, and criteria to adapt and modify existing products and processes.
  • Review procedures and plans before implementation, and evaluate existing products, processes, and materials for failure analysis and potential improvements.
  • Investigate, develop, document, and implement new product and process technologies of moderate complexity and scope as part of projects.
  • Perform technical project work using Integer's standard quality management and production system methodologies to investigate product and process improvement opportunities.
  • Apply standard data analysis practices and techniques to establish root cause for product and process failures or justify improvements.
  • Observe products and processes for discrepancies in results, and follow operations through detailed steps or processes to establish root cause.
  • Collaborate with others, exchange information, ask questions, and regularly check for understanding to support professional 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 line supervision.
  • Support Integer's Manufacturing Excellence and Market Focused Innovation strategies.
  • Champion development and deployment of systems and tools that drive innovation and continuous improvement.
  • Support Manufacturing Excellence through Strategy Alignment (Site Hoshin Plans, Sales, Inventory, and Operations Planning meetings, and value stream map updates); Leadership of Sustained Change (production monitoring and improvement activities and Leader Standard Work); Standardization (workplace organization and visual controls, Manufacturing Standard Work, and training and certification programs); Associate Engagement (standardized problem-solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems); and Systems and Process Optimization (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 defined goals and objectives and project milestones, contribute to site quality key performance indicators, and 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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