Senior Manager, Manufacturing Engineering
4 days ago
QUALIFICATIONSRequired:Bachelor's Degree in a technical discipline (e.g., Engineering or Science) and/or education/experience equivalentA minimum of 8 years of experience in process/equipment design and development to support new product development and manufacturingExperience leading cross functional teams, projects, and/or direct reportsExperience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testingExperience with Product DFMA (Design for Manufacturing and Assembly)Preferred:Experience in a high-volume manufacturing environment preferred, i.e., production 1M+annual, cycle time < 1 secondExperience with customequipment procurement and qualification such as via the GAMP processSkills & Competencies:Leadership – ability to create a vision and motivate employees to strive to create that visionAttention to detailStrong influencing and negotiating skillsExcellent verbal communication and technical writing skillsProficient with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)Understanding and application of 21 CFR 820 Medical Device Quality System Regulation, especially 21 CFR for equipment qualification and 21 CFR for process validationExperience with the validation life cycle (planning, protocol writing, execution, report writing)Understanding and application of Good Automated Manufacturing Practice (GAMP)Proficient with the MS Office Suite (Word, PowerPoint, Excel, Visio)Physical Requirements:Must be able to remain in a stationary position for extended periods of time (desk work).Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.RESPONSIBILITIES:Lead direct reports such as manufacturing engineersDelegate and prioritize tasks to align with corporate strategiesLead the design and development of manufacturing processes and equipmentReview and approve manufacturing process documentationCreation of manufacturing process development documentationEquipment qualification (installation, operational and process qualifications (IQ/OQ/PQ)) to meet regulatory requirementsCreate test protocols to challenge equipment performance against intended specificationsExecute protocols and write validation reportsProcess validation to meet regulatory requirementsWrite protocols, execution of the protocol, and write the validation reportStandard operating procedures create, revise, and implement including necessary change order, training, and verification activitiesTest methods, write and execute test method validations such as Gauge R&R studiesProject management, prepare overall project proposals including cost estimates and schedule for designated projectsAssign priority and schedule tasks to provide timely solutions to achieve resultsParticipate in cross functional teamsOther duties as assignedJob Type: Full-timePay: From $124,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programEmployee discountFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offVision insuranceWork Location: In person
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