By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right 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.
Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling.
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.
Provide support of Integer's Manufacturing Excellence and Market Focused Innovation Strategies
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.
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:
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.
U.S. Applicants: EOE/AA Disability/Veteran
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