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Design Assurance Engineer II- Chaska
Integer Holdings Corporation
- United States
- United States
About
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 Key Accountabilities and Responsibilities: 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. As a quality Core Team member, actively participate in development project teams. Perform quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. Generate and/or review related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports. Participate in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development. Support Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods. Coordinate the preparation of Quality Plans, including inspection and gauge requirements. Provide support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required. Coordinate sourced item qualification activities and supports supplier risk management initiatives. Perform other functions as required. Job Requirements: Minimum Education: You earned, as a minimum, a bachelor's degree in an engineering or related technical field; and have at least three years of relevant experience. Candidates who do not meet the education requirement may be considered with 7+ years of relevant experience. Specialized Knowledge: Experience with statistical software packages such as Minitab. Demonstrated problem solving skills. Knowledge of ISO and FDA quality, process validation and system requirements Experience in interpreting design schematics and drawings Skilled in statistical methods e.g. ANOVA, SPC, sample size determination, Gauge R&R and DOE. Knowledge of quality lean sigma tools (e.g. Root Cause Analysis, QFD, Ishikawa, Kepner-Tregoe). Special Skills: Strong written and oral communication skills, including technical writing. Demonstrated ability to work in a team environment. Salary Range: $79,200-$116,160 #IND1 Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off. U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
Languages
- English
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