Design Assurance Engineer

2 months ago

Clarence, United States Integer Holdings Corporation Full time

Job Description Summary

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 that enable greater efficiencies.
  • Innovation and ideation are critical aspects of your role and you will be expected to generate continuous improvement suggestions and support the implementation of them.
  • Your expertise coupled with your accomplishments and collaboration with others to deliver results will also be considered.

What sets you apart:

  • You earned, as a minimum, a Bachelor’s Degree in an engineering or related technical field and may have earned a Master’s Degree.
  • You are technically seen as a very competent technical contributor, a recognition you have earned through 5+ years of progressive engineering and/or technically focused roles and experiences.
  • Candidates who do not meet the education requirement may be considered with 10+ years of relevant experience.
  • You have a strong technical and problem solving foundation, and preferably training and certifications, in a variety of problem-solving and project management methodologies such as 6-Sigma (green belt as a minimum, black belt preferred), 8D, RCA, 5-Why, Ishikawa (Fish Bone), Kepner-Tregoe, PMP.
  • Your abilities to observe, analyze and develop solutions to challenging technical issues result in the delivery of measurable results in areas such as productivity, technical capabilities, capacities, or other competitive differentiators.
  • You work independently as well as collaboratively with cross functional teams.
  • You will demonstrate the ability to lead team activities and act as a coach for other less experienced associates.
  • Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
  • You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
  • You possess a positive, can-do attitude with an underlying belief that failure is not an option.

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