Senior Manufacturing Engineer

Senior Manufacturing EngineerThis position will be responsible for the development, qualification, verification and validation of manufacturing processes. The Senior Manufacturing Engineer will contribute in creative and collaborative way to achieve the company's goals of producing market lead products through positive patient outcomes.Essential functions of the position include:Review of component designs and identification of Design for Manufacturing opportunities.Review of proposed component tolerances and input to manufacturing capability.Review of proposed device assembly requirements and identification of Design for Assembly opportunities.Provide input to systems test requirements for ongoing production.Definition of high-level manufacturing system/flow.Selection of suppliers for parts and equipment.Coordination of parts and equipment fabrication.Manufacturing process knowledge includes:Knowledge of general manufacturing technologies including low to medium volume manufacturing processes.Work with outside suppliers to define, document, analyze and qualify their manufacturing processes.Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost.Lead the definition, development, verification, and validation of manufacturing processes for new products. Develop manufacturing processes that are simple, cost-effective and reliable.Identify and implement manufacturing and product-related cost reduction opportunities. Understand life-cycle costs and cost-benefit analysis.Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.Tooling and equipment responsibilities include:Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these conceptsUnderstanding of ergonomics as related to repetitive stress injuriesWork with designers and engineers in the design and development of manufacturing-related equipment and fixturesDefine and track project tooling and equipment schedule and costResponsible for proper installation of new equipment, and setting up proper preventive maintenance and calibration plansVerification and validation responsibilities include:Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standardsResponsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes. Also using the output to determine in-process testing and product final inspection requirementsResponsible for writing and executing process qualification protocols and reports. Understanding of IQ, OQ, and PQ approach as defined by AtriCure Quality SystemManufacturing logistics responsibilities include:Understand supply chains, lead times, and raw material availabilityResponsible for make vs. buy decisions on parts and processesAble to construct Bills of Material, with proper unit of measure and inventory pointsWorking knowledge of MRP and other requirement planning systemsAble to create manufacturing routers. Understands labor collection and work centersUnderstanding of standard costing and variances. Able to conduct time studies and analyze cost variancesDocumentation responsibilities include:Properly document all work in compliance with AtriCure Quality System requirementsResponsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systemsWrite detailed, easy to understand process instructionsWrite detailed test protocols and reports to document qualification activitiesDevelop process maps and FMEAs for all processesCapable of documenting intellectual property (i.e. Lab Notebook)Communication responsibilities include:Responsible for communication of manufacturing and process issues to cross functional development team and suppliers, both verbally and in written documentationThe individual must have proficiency in computer communication tools and design documentation (Microsoft Office products)Leadership and planning responsibilities include:In charge of planning work to track tasks that align with project plan and team objectivesDevelop and communicate best practices among other manufacturing engineersResponsible for guiding the efforts of more junior manufacturing engineers and techniciansAdditional essential functions of the position include:Regular and predictable work performanceAbility to work under fast-paced conditionsAbility to make decisions and use good judgmentAbility to prioritize various duties and multitask as requiredAbility to successfully work with othersAdditional duties as assignedBasic qualifications include:Bachelor's degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience6+ years of experience in a comparable positionAble to function as lead manufacturing engineer for product development teams with minimal guidanceDemonstrates proficiency in selection and qualification of manufacturing processesAble to provide input into the design of the product based on manufacturing methods and capabilitiesAble to review product designs relative to achievable component and system tolerancesDemonstrates proficiency in coordinating the design and development of equipment and fixturesDemonstrates proficiency in developing and executing process qualification strategiesUnderstands the importance of manufacturing documentation, and sufficient understanding of manufacturing logistics to guide strategy decisions by the design teamsConveys ability to work and communicate in a cross-functional environment, including Marketing, Quality, Manufacturing, and Regulatory departmentsDemonstrates the ability to plan and track tasks to align with project plan and team objectivesInspection/testing experienceData analysis experienceComputer/data entry skillsWritten/report writing skillsVerbal communication skillsProblem solving/troubleshooting experienceAbility to read technical specificationsAbility to read blueprints, drawings, and specificationsPreferred qualifications include:Graduate degreeAssembly and machining experienceComputer networking experienceSupervision experienceRegulatory experienceStatistical use experienceEngineering/design backgroundFinancial analysis experienceOther requirements include:Ability to regularly walk, sit, or stand as neededAbility to occasionally bend and push/pull as neededAbility to regularly lift up to 10 pounds, occasionally lift over 10 poundsAbility to pass pre-employment drug screen and background check