Senior Project Engineer
Company: Conmed - Linvatec Corp
Posted on: February 3, 2019
Senior Project Engineer The mission of the Senior Project Engineer is to coordinate all activities in support of the release of new products to production. The Senior Project Engineer must maintain timelines, action item lists, and all necessary documentation for design control per FDA 21 part 820 QSRs and ISO 13485 and ISO 9000. This engineer is the focal point for communicating project status to management and for communication and coordination of all project activities. To accomplish this mission, they must work closely with marketing, engineering, and operational departments to keep critical projects on timeline. Knowledge of product development in a medical device design environment, leadership skills, and the ability to work with others are essential. Duties and Responsibilities: * Maintain timelines, task lists, and action item summaries. Convene and lead efficient project meetings with formal agendas and summary meeting minutes for a multi-disciplined design control team. Identify critical path items and work with appropriate departments and/or outside vendors to manage critical tasks. Provide resource requirements for projects and communicate with management concerning critical resource issues. Ensure that projects are released to production with full support of all departments. * Plans, conducts and directs engineering projects involving 2 or more smaller projects and a major project. * Coordinates engineers and technicians assigned to projects and schedules work to meet completion dates and technical specifications. * Direct and support design control documentation requirements according to FDA 21 part 820 QSRs and ISO 13485 & 9000. Maintain engineering drawings as required to incorporate design or process changes. Create and present necessary ECR's and ensure changes are properly documented and validated per ConMed procedures. * Reports project status to middle and upper management. * Planning, performing and/or supervising the range finding and V&V testing of products including developing test methods, protocols, and reports. * Participate in and lead design reviews. * Primary responsibility for creating and maintaining design history folders for all projects according to FDA and ISO regulations. Work with RA & QA to ensure DHF's and technical files contain all necessary elements to satisfy regulations. Requirements: Work Experience: 7 to 10 years' experience with medical device product development. Practical experience with leading projects from concept to commercialization. 3-5 years project management experience. Education: B.S. in Mechanical or Biomedical Engineering or a technical equivalent. Master's Degree is desirable. PMP/PRINCE Certification is desirable. Knowledge: Working knowledge of Project Management principles and FDA 21 part 820 QSRs and ISO 13485 & 9000 Regulations. Physical: Light physical effort -- lifting or moving up to 40 pounds. Frequent sitting, walking, and standing. Travel: 10-30% travel, some international CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows. We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, NJ, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East. Benefits CONMED offers competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage Short & long term disability plus life insurance -- cost paid fully by CONMED Retirement Savings Plan (401K) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price Tuition assistance for undergraduate and graduate level courses CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran statusSDL2017
Keywords: Conmed - Linvatec Corp, Largo , Senior Project Engineer, Engineering , Largo, Florida
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