Senior Manufacturing Engineer job

Senior Manufacturing EngineerThe Senior Manufacturing Engineer applies engineering principles to the planning, design, manufacturing process development, documentation, and testing of surgical devices / equipment. Demonstrated knowledge in Design for Manufacturability, Lean Methodologies / Tools, Design of Experiments (DOE), Statistical Process Control (SPC), and product and process characterizations. Development of Process Failure Mode Effect Analysis (pFMEA) during manufacturing process development and change. Investigates product failures and develops methods to prevent recurrence. Must be familiar with CAPA process. Defines approaches to test method operation, implementation and provides training of the test methodology. Design transfer and validation of new products.Duties and Responsibilities:Develop SOPs and manufacturing instructions and update existing documentation as needed in a timely mannerConduct root cause analysis and lead CAPA investigationsFocus on critical deliverables and high priority projects, acting as a hands on resourceAbility to create and execute characterization protocols and design of experimentsDrive test method improvementsEnsure Good Manufacturing Practices (GMP) are appliedExperience in the utilization of SolidWorks CAD and analysis toolsCreate and implement verification and validation plans for systems and subsystemsEnsure all FDA and related regulatory requirements are consistently metExplore and pursue innovation/technologies and integrate them into the manufacturing operationsParticipates in research and development activities as the manufacturing engineering representativeResponsible for design transfer from R&D to an internal manufacturing site under a regulated medical device environment. This individual will drive day to day activities will include conducting research, data analysis and process development studies to support design transfer activities. The candidate will also participate in cross-functional project teams, and author and/or review protocols and technical reports to support the Device Master Record (DMR).Define problems and objectives, develop approach, analyze results and provide recommendationsProactively develop and maintain technical knowledge in specialized area(s), remaining up-to-date on current trends and best practicesSupports post-launch to resolve performance and/or quality issuesLead the design, execution, analysis and study documentation to support new product launchesDesign & implementation of automation technologies within the manufacturing operations leading to overall quality & efficiency improvementsDefine and translate new product requirements into product designs and performance specificationsCollaborate with internal and external partners to achieve project objectives and deliver timely innovative solutions to meet business needsIncorporate appropriate statistics methods into experimental design and analysisQualificationsBachelor's degree in Mechanical, Manufacturing, or Automation Engineering, with a minimum of 5+ years of experience or Masters of Science degree with 3+ years of experience in the medical device industryExperience in medical device specifically in surgical devices / equipmentKnowledge of FDA / ISO quality systems specifically Design Controls / Product Development Process & 21CFR820 and related requirements.Understanding of product development and manufacturing methodologies to achieve high quality designs (design reliability) & manufacturing yieldsExperience in the utilization of SolidWorks CAD and analysis toolsDemonstrated skills in the following areas: Mechanical / systems design, design for reliability / manufacturability, CAPA, materials and component selection, test fixture design, hydro pneumatic and fluidic sub-system design, design characterization, verification, and validation activities, excellent communication skills, ability to lead projects within own functional discipline, root cause analysis / problem solvingExperience in the design & implementation of automation technologies within the manufacturing operations leading to overall quality & efficiency improvementsHands-on experience with Lean Methodologies / Tools such as 3PExperience in process Failure Mode & Effect Analysis (pFMEA) and risk analysisEnsure best practices are being utilized and leading continuous improvementsAboutCONMED 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 coursesCONMED 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 status.
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain