Manufacturing Engineering Director
Company: Conmed - Linvatec Corp
Posted on: November 3, 2018
Manufacturing Engineering Director The Manufacturing Engineering Director will provide overall leadership and management for the Manufacturing Engineering Group. He or she will apply engineering and principles to the planning, design, manufacturing process development, documentation, and testing of medical device products. Development of responsibilities for this position will include overseeing all manufacturing line support / manufacturing engineering activities as well as product / process improvements including cost reductions in the manufacturing of medical devices support new product transfers to manufacturing, overseeing technology development in accordance with company strategies, facilitate the transfer of manufacturing methods and or technologies within the company and or external business partners, develop and maintain all manufacturing documentation / work instructions. Develop and maintain strong collaborative partnerships with other sister sites, joint ventures, and OEMs; and ensures all FDA, ISO, GMP, and related regulatory requirements are consistently met. This is a key leadership role within the company driving key operational metrics including financials. Responsibilities: * Set direction based on manufacturing engineering and quality / financial requirements and drives his / her team to meet these requirements. The team consists of various engineering disciplines. * Development of Design of Experiments (DOE), Statistical Process Controls (SPC), process Failure Mode & Effect Analysis (pFMEA) and product and process characterizations and validations. * Define approaches to test method operation, implementation and providing training of test methodology * Design transfer and validation of new products * All manufacturing engineering activities within the business unit manufacturing organizations that affect the successes of the company and customer satisfaction * Ensure a safe work environment for all associates and drive to eliminate any environmental, health, and safety incidents * Identification & implementation of automation / efficiency improvement opportunities * Identify, implement, and track both long and short term strategies that ensure positive results in the areas of manufacturing & operational excellence * Determine and monitor the overall resource capacity (personnel & equipment) for the organization and set priorities accordingly * Ensure quality procedures are developed & sustained in accordance to our Quality System ensuring our customers receive the highest quality product * Ensure that goals are being met around the key metrics all while maintaining product quality and compliance * Act as a role model to company personnel and be recognized as a leader * Assess, identify, and implement technological advancements * Drive continuous process improvements activities utilizing lean manufacturing principles and tools * Identify, benchmark, and implement the use of best practices * Communicate with appropriate outside sources to provide resolution to customer and company questions and concerns and other quality related issues as they arise * In partnership with functional group and the specific site lead, establishes and approves operational objectives and assignments * Communicates issues to management, users and staff that can have company-wide impact * Develop SOPs and manufacturing instructions and update existing documentation as needed in a timely manner * Conduct root cause analysis and lead Corrective Action Preventive Action (CAPA) investigations * Identify & drive cost savings projects * Focus on critical deliverables and high priority projects, acting as a hands-on resource * Ability to create and execute characterization protocols and design of experiments * Create and implement verification and validation plans for systems and subsystems * Ensure all GMP / FDA / ISO and related regulatory requirements are consistently met * Participates in research and development activities as Manufacturing Engineering Lead * Responsible for design transfer from R&D to an internal manufacturing site under a regulated 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 * Define problems and objectives, develop approach, analyze results and provide recommendations. * Proactively develop and maintain technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices. * Supports pre & post-launch project activities ensuring Design for Manufacture" concepts are followed including 3P & address / resolve any issue hindering successful transfer & release * Lead the design, execution, analysis and study documentation to support new product development * Incorporate appropriate statistics methods into experimental design and analysis * This position requires a combination of leadership and hands-on technical skills, and it is expected that the individual has relevant experience in Advanced Manufacturing Engineering principles to understand and manage the resolution of complex technical issues * Plans and or performs studies for the development, evolution and optimization of medical device products within well-defined boundary conditions and timelines * Perform and summarize experiments, participates in identifying technical issues and recommend resolution. * Experience in the orthopedic surgical products / devices / implantables * Provides technical expertise to improve and maintain performance, efficiency and quality of manufacturing operations * Supports the manufacturing operation leading investigations, validations, risk assessments, raw material evaluations, etc * Specify, document, and monitor scientific and engineering parameters to ensure process safety, control and performance * Drive continuous improvements activities utilizing lean manufacturing principles and tools Qualifications * Bachelor's degree in Manufacturing or Mechanical Engineering with 7 -- 10 years of experience in medical device / regulated industry, Masters or MBA degree with 5 -- 7 years of experience in key leadership roles within a manufacturing operation with at least 5 years in a management position. * Demonstrated experience in the medical device, orthopedic, or surgical industry * Experience working in an FDA / ISO / GMP regulated environment * Demonstrated / hands-on experience with the Lean Methodologies / Tools * Leadership and management experience in developing high performance teams across multi-departmental organizations * Hands on experience with multiple manufacturing processes including automation * Demonstrated ability leading a major sustained improvement effort. * Proactive, results-oriented, self-motivated team player with strong organizational skills and excellent written and verbal communication. * Team player with strong customer orientation and ability to work in multinational and multicultural environment. * Knowledge of SolidWorks, Pro/Engineer or other CAD programs * Demonstrated experience with the successful use and implementation of Lean Six Sigma / Toyota Production System tools & methodologies such as SMED, 5S, OEE, TPM, etc. as well as personally leading Kaizen events * Excellent analytical, interpersonal, verbal and written communication skills. 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 , Manufacturing Engineering Director, Executive , Largo, Florida
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