Changing lives. Building Careers.

　　Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

　　ESSENTIAL DUTIES AND RESPONSIBILITIES

　　Understands and applies basic principles of Design Controls

　　Lead and manage the Design Control process for Medical Device product development

　　Assists with exploratory research, insights gathering and identification of new product concepts

　　Develops a strategy and plan of execution using his/her scientific knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project

　　Develop and implement tools and processes that nurture a culture of innovation and excellence

　　Uses expertise to improve operational efficiencies and meet compliance requirements

　　Summarizes, interprets, reviews data, draws conclusions, and independently presents and proposes next steps.

　　Manages processes and ensures that goals are achieved

　　May act as team leader and/or mentor junior professionals

　　Advises project team management of resources needed to accomplish scientific project.

　　Collaborate with Manufacturing to transfer developmental products into manufacturing, sharing responsibility for Verification & Validation

　　Work with external vendors, consultants, and collaborators to facilitate project work

　　Interact with customers to assure design requirements are established and met

　　Prepare quality system compliant documents for equipment, processes, product specifications, etc.

　　Assists in planning and execution of Safety and Performance testing of products consistent with varying levels of regulatory and clinical requirements

　　Establishes priorities, checkpoints, and timelines for experimental work in support project objectives

　　Effectively applies broad scientific knowledge and shows a high level of scientific and technical proficiency in own field.

　　Demonstrates reasonable knowledge/expertise outside of own field

　　Employ interpersonal, communication and negotiation skills with all levels of personnel and management to facilitate information flow among team members

　　DESIRED MINIMUM QUALIFICATIONS

　　A B.S. with 5+ years of experience; An M.S. with 3+ years; A Ph.D. degree with 2+ years industry experience.

　　Experience in product development and application of design control

　　Experience in processing biomaterials including xenografts, allografts and synthetics

　　Experience and understanding of US FDA, GMP and ISO requirements for device development

　　Excellent verbal and written communication skills

　　In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.

　　Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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　　EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

　　Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected] or call us at 855-936-2666.

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