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Director, Design Assurance

Overview
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
Responsibilities
Represents Global Quality Assurance on the New Product Introduction (NPI) cross-functional team (CFT) when required. Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Global Operations, Global Service and Marketing to ensure specific product development metrics are met.
Plans and leads intra-divisional initiatives.
Works with Divisional personnel to ensure all elements of the NPI process are understood and delivered.
Support Process Validation activities, including identifying key reuirements that may be associated with the medical device.
Participate in Design Reviews for NPI teams to ensure design and process robustness and compliance to Corporate and Divisional design control policies.
Leads the exercise of understanding the functional inputs and outputs of the medical device.
Analyzes reports and recommends corrective action.
Periodically audit Design History Files across all divisions to ensure full compliance
Plans and develops complex process and product protocols and monitors progress.
Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485, MDD) and how to apply the principles, practices, and procedures
Provides and/or reviews advanced statistical techniques for test sample size determinations.
Uses and/or reviews advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing.
Supports complex projects to ensure sound application of quality engineering principles are used, and design intent is being achieved.
Plans and verifies that new complex engineering devices are technically sound and in compliance with FDA and other regulatory bodies.
Plans, performs, and reviews complex engineering risk analyses to manage technical difficulties encountered with new medical devices.
Provides leadership in the NPI process by identifying effective test methods.
Provides leadership and influence among multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met.
Plans, improves, and/or supports complex processes.
Possesses and applies comprehensive knowledge of particular field of specialization to the completion of complex assignments (i.e Process Validation)
Demonstrates technical leadership as an inter-departmental resource.
Represents Corporate QA during Design and Gate Reviews
May work with verbal and/or written instructions.
May train others in quality assurance /Quality Engineering / GMP related topics.
May direct and/or evaluate the activities of one or more Design Quality Engineering technicians, Associate Design Quality Engineers, Design Quality Engineers, Sr. Design Quality Engineers, Staff Design Quality Engineers, or Sr. Staff Design Quality Engineers.
Ability and willingness to travel 30%
Qualifications
Bachelor's degree in an engineering or science field.
Master's degree in an engineering or science field desired.
Minimum of 7-10 years of experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
Demonstrated compliance fluency as per QSR, GMP and ISO regulations.
Thorough understanding of validation principles, testing procedures; analytical, statistical methods, and problem solving skills
Six Sigma Green Belt preferred; Six Sigma Black Belt desired.
ASQ CQE preferred.
Strong verbal and written communication skills; ability to present issues, plans and objectives.
Excellent organizational, problem solving, and analytical skills
Ability to manage priorities and workflow
Versatility, flexibility, and a willingness to work within constantly changing priorities
Ability to handle multiple projects and meet deadlines.
Good judgment with the ability to make timely and sound decisions.
Working knowledge of data collection, data analysis, and evaluation, and scientific method.
Ability to observe and note minute inconsistencies.
Ability to generate, follow, and explain detailed instructions and inspection procedures.
Ability to complete detailed documentation accurately.
Ability to analyze and resolve routine issues using independent judgment



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