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Advanced Manufacturing Engineer

Irvine, CA, United States

Posted on
May 23,2019

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Job Description: Summary Job Description BD Interventional's Surgery business unit is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties. Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company. The Irvine Plant is situated in in the heart of Orange County with easy access to the expansive coastline, John Wayne Airport, Amtrak and Metrolink. Our office is within a 20 minute drive to local attractions including Laguna, Huntington and Newport beaches, Disneyland, Los Angeles Angels Stadium, the Honda Center of Anaheim, and is just a short distance to San Diego and Los Angeles. Summary of Position with General Responsibilities: Experienced engineering resource to improve the competitiveness of the organization in a performance based team environment. Completes projects by utilizing team leader and project management skills to lead multidisciplinary teams. Responsible for manufacturing support that includes development, qualification and implementation of processes, methods and equipment. Essential job Functions: Drives continuous improvement, improved safety and cost reductions. Participates in cross-functional project teams and executes individual project tasks. Establishes and maintains manufacturing documentation and drawings. Supports facility's Quality System and tactical plans. Develops manufacturing processes and methods. Designs, develops, qualifies, and validates manufacturing processes and tooling/equipment. Performs mechanical/electrical testing and Gage R&R studies. Statistically analyzes data (e.g. process capability, Design of Experiments). Troubleshoots processes, equipment, quality systems and develops/implements corrective and preventive actions. Exercises independent judgment to perform job responsibilities, including taking the lead in managing projects. Provides sound engineering judgment and decisions. Knowledgeable on materials for Sealant Franchise product designs in areas of responsibility. Qualifies and validates new material and suppliers. Effectively trains manufacturing employees on specifications and processes. Authors CRs, protocols, technical reports and AFEs. Technical interface with manufacturing teams. Leads small cross-functional project teams. Organizes and effectively leads meetings. Trains production operators. Coordinates Non-Conforming Material / CAPA Activities with QA. Performs special projects and other duties as assigned. Basic Qualifications: Knowledge/experience working in an FDA regulated environment. Ability to use design software, SolidWorks 3DCAD and Microsoft Project or equivalent. Statistical Analysis Experience Preferred (JMP, Minitab) Experience working in clean rooms; liquid filling processes preferred. Ability to build strong partnerships with QA and R&D teams. Fluent in English. Good Technical Writing Skills. Education and/or Experience: B.Sc. degree in chemical engineering, mechanical engineering, or related discipline with a minimum of 4 years relevant experience (or) M.S. degree in chemical engineering, mechanical engineering, or related field with a minimum of 2 years relevant experience. Physical Demands: Travel Approximately 10% of work time will be spent traveling. Physical demand - the physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee will be required to lift or moved at least 50 pounds. Mental demand - Moderate to high degree of concentration due to volume, complexity, and/or 'pressure' of work. Expected to meet project deliverables that may require significant time commitments and support. Work Environment: BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor. Primary Work LocationUSA CA - Irvine Neomend Additional Locations Work Shift

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