Senior Manufacturing Engineer

Sr. Manufacturing EngineerMVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems. More than 50 years ago, they set the standard for storage of biological materials at low temperatures. Today, they continue to exceed these standards. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today's biomedical life sciences industry.The Sr. Manufacturing Engineer provides support and solutions by leveraging general knowledge of manufacturing processes to increase plant efficiencies and meet, or exceed, goals related to safety, quality and production. The Sr. Manufacturing Engineer will also regularly employ software tools to aggregate test data, troubleshoot equipment, and develop layout drawings. The ideal candidate will demonstrate deep technical knowledge, excellent communication and organizational skills, and strong personal ownership of initiatives.PRIMARY RESPONSIBILITIES (include but not limited to):Plan, organize and implement systems and procedures for aiding in the manufacturing of MVE products while enhancing flow, and implement Lean concepts (e.g. 5S, Visual Work, Kanban) throughout the plantPersonally conduct and/or supervise studies to determine cause, effect and the corrective measures required to remedy deviations impairing desirable standards of qualityAnalyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiencyPartner with the Design Engineering groups to ensure that all aspects of new product introduction and changes to existing products are properly transitioned into manufacturingDevelop and perform qualification and validation activities for newly introduced equipment, processes, & productsPartner with production, engineering, and maintenance departments and apply formal problem solving tools (e.g. 5 Why's, 8D, Ishikawa diagram) to resolve assembly errors and eliminate variancesWork closely with team members to identify and eliminate waste activitiesIdentify, recommend, and justify opportunities for capital equipment improvementsProject Management of Capital equipment projects, and ensuring on time delivery, managing budgetary constraints, and ROIPerform hands-on mechanical and electrical troubleshooting of production equipment, including some PLC troubleshootingObserve and promote safety procedures and policiesOther duties and responsibilities as assigned by managementCOMPETENCIES AND PERSONAL ATTRIBUTES:Must possess a working knowledge of computers, including MS Word, Excel, and SolidWorksGeneral familiarity of medical device or similar quality systems requirementsUnderstanding of MIG/TIG welding practices, sheet metal fabrication, cryogenics, and vacuum systems, a plusUnderstanding of factory metrics, Lean (Operational Excellence) and Six Sigma, a plusKnowledge and understanding of company safety procedures and policiesAwareness and understanding of Company quality standards, capital equipment, procurement, FMEA, APQP, ISO 13485, MDD/MDR, FDATeam player mentality with a passion for, and alignment with, MVE's missionAn individual who brings strong core values, quality, ethics, and integrityA team player who embraces and champions the culture of collaboration and accountabilityStrong work ethic and ability to deliver results and meet commitments in a dynamic environmentExceptional and dynamic communication skills with the ability to inspire and influence othersAn individual who works efficiently, effectively prioritizes and drives towards our corporate goalsExceptional organizational and planning skills, strong analytical abilities, and process orientationDemonstrates a business process orientation to developing solutionsQUALIFICATIONS AND EDUCATION REQUIREMENTSBS degree in Engineering, preferably Manufacturing, Mechanical or Industrial3 –5 years of relevant Medical Device Manufacturing experience; or a minimum of 10 years of experience in a related field. Experience must reflect increase in scope and complexity of duties and responsibilities.Six Sigma Black Belt certification required, with a proven track record of leading and delivering measurable process improvement projects.PHYSICAL WORK ENVIRONMENT REQUIREMENTSAbility to work in both an office and production environmentOccasional travel to customers, vendors, or other MVE locations is possibleAbility to sit, stand, and/or walk for 8 hrs/dayOccasional lifting of up to 30 lbs., occasional heavier liftingOccasional pushing, pulling and handling of materialsProduction floor environment will involve possible exposure to materials with rough edges, temperature extremes, moving mechanical parts, occasional flying debris, chemical cleaning solvents and their odorsThis position will require the ability to move around the production floor and lab areas to address production issues relating to products and equipmentWorking with cryogenic products will involve possible exposure to pressurized flammable gas, pressurized oxidizing gas, pressurized inert gas and very low temperatures (-320º F)