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Design Assurance Engineer III

Company: Integer Holdings Corporation
Location: Plymouth
Posted on: April 2, 2021

Job Description:

At Integer, our vision and values are embedded in everything we do!-- If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now! 1. Adheres to Integer Values 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. Builds consensus where appropriate. 3. Leads Risk Management (ISO 14971) activities. May leads cross functional teams in planning, analyses (DFMEA, FTA, Risk/Benefit) and mitigations. Maintains risk management file for the life of the device.-- 4. Generates and/or reviews related project deliverables such as: design verification and design validation protocols and reports as well as process validation protocols and reports. Coordinates with R&D in the review of technical documentation. 5. Works with Product Development Manufacturing Engineering in the development of test fixtures, develop production acceptance criteria and test methodology. 6. Coordinates sourced item qualification activities and supports supplier risk management initiatives. Conducts Independent review of DHF and Technical files, provides technical standards interpretation, and determines appropriate statistical methods, including sample size determination. 7. Provides support in conducting root cause analyses, preparation of CAPA and Distributed Product Risk Assessment. Draft and update SOPs as required.-- 8. Performs other functions as required. Job Requirements Minimum Education: Bachelor's Degree in Engineering or related field required. Master's Degree preferred. 5-7 years of experience. Specialized Knowledge: --- Practical knowledge of FDA Quality System Regulations, ISO 13485 and Medical Device Directive. --- Practical knowledge of ISO 14971, and related standards --- General familiarity with industry best practices in development, testing and manufacturing processes.-- --- Experience in interpreting design schematics and drawings. --- Preferred experience with FDA and European regulated medical devices --- Skilled in statistical methods e.g. ANOVA, SPC, test sample size selection plans, Gauge R&R, and DOE. --- Experience in establishing and implementing quality metrics for product development. Special Skills: --- Strong collaboration, negotiation, and conflict resolution skills. --- Excellent verbal and written communication skills.. Posted 2 Days Ago Full time R8104 About Us Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net . Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and--gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at

Keywords: Integer Holdings Corporation, Plymouth , Design Assurance Engineer III, Engineering , Plymouth, Massachusetts

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