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Senior Process Development Engineer - Medical Device

Company: Avanos
Location: Alpharetta
Posted on: October 12, 2020

Job Description:

Requisition ID: 2252 Job Title: Senior Process Development Engineer - Medical Device Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com. The role The Senior Process Development Engineer will report to the Manager of Advanced Process Development R&D responsible for the medical devices business. They will be responsible for design, development, and commercialization of processes and equipment for existing products and other new medical devices. They will work with project teams and leaders to create/redefine product specifications through innovative and robust processing solutions. They will be responsible for test development, protocols and reports related to verification and validation device testing. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States. Essential Duties and Responsibilities: Provide technical leadership on new medical devices, by designing and developing manufacturing processes and related fixtures and tooling that are consistent with low defect levels and low product cost. Be the subject matter expert (SME) on any given project, and act as project lead to provide updates when the project leader is unavailable. Conferring with vendors in determining product specifications and arranging equipment, parts, or material purchase, and evaluating products according to quality standards and specifications. Estimating staffing requirements, production times, and relative costs to provide data for operational decisions. Working closely with the local manufacturing department to develop, coordinate, and implement technical training for employees. Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&E and quality assurance functions. Supporting company policies and procedures, goals and objectives, FDA regulations, and goods manufacturing practices. Research and purchase new manufacturing technology, work in collaboration with the local engineering department to better production equipment functionality. Implement the transition of new technology to make sure production continues successfully without any delays. Act as a mentor to junior engineers within the Process Development Group. Your qualifications Required: Bachelor---s Degree or advanced degree in Industrial, Manufacturing, Mechanical or Electrical Engineering, or similar field. A minimum of 10 years--- experience in a variety of technical and/or operational assignments. Strong experience using manufacturing analysis tools; such as but not limited to, DOE (Design of Experiments), process capability studies, Six Sigma etc. Working knowledge of solid modeling (Solid Works preferred). Familiar with writing validation protocols, execution and thereafter data analysis. Performed design transfers of new products from initial concept through launch. Experience with working with external service providers. Knowledge of engineering principles, scientific analysis, and project management. Must be a good communicator-written and verbal. A second language-Spanish would be an advantage. Comfortable with giving technical presentations within and outside of Avanos. Ability to prioritize multiple projects. Must be able to work in a team environment and meet deadlines. Willing to travel as needed up to 50% at times in order to collaborate with vendors, some international. Preferred: Master---s Degree in Engineering. Experience in medical device manufacturing assembly processes including but not limited to-PU balloon forming, RF tipping equipment, Pad printing, UV/Thermal adhesive dispensers, vision systems and leak testing equipment. Knowledge of polymer processing techniques. Strong knowledge and background in mechanical engineering, with a strong ability to translate that knowledge into execution of process capabilities in major projects. Green Belt in Lean Principles --- Black Belt a Plus. Ability to grasp modern technologies quickly. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here . Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees --- through a comprehensive and competitive range of benefits. We provide more than just a salary --- our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. free onsite gym - onsite cafeteria - 401(k) 6% match - immediate vesting - benefits on day 1 - uncapped sales commissions - HQ region voted ---best place to live--- by USA Today

Keywords: Avanos, Alpharetta , Senior Process Development Engineer - Medical Device, Other , Alpharetta, Georgia

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