Design Assurance Engineer I

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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 position is to support new product development activities to ensure that the desireddesign performance is achieved meeting the applicable medical device FDA/European regulatory requirements and the company's Policies & Procedures. The Design Assurance Engineer will ensure a successful transfer of newlydeveloped product to production, while supporting design concept phases through launch.
Key Accountabilities and Responsibilities:
1. Adheres to Integer's Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements. 2. As a quality Core Team member, actively participates in development project teams. Performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls and test requirements are fulfilled. 3. Assists in the preparation of related project deliverables, such as design verification and design validation protocols and reports; and process validation protocols and reports. 4. Participates in risk assessment and mitigation activities (FMEA, FTA, etc.) in support of new product development. 5. Supports Product Development Manufacturing Engineering in development of test fixtures/ test methodology, develop production acceptance criteria and test methods. 6. Participates in the preparation of Quality Plans, including inspection and gauge requirements. 7. Provides support for root cause analyses, CAPA and Distributed Product Risk Assessment and updates SOPs as required. 8. Supports sourced item qualification activities and supports supplier risk management initiatives. 9. Performs other functions as required.
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.
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Location:
Palm Harbor, FL, United States
Category:
Architecture And Engineering Occupations

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