Manufacturing Operations Specialist IV
Fusion Life Sciences Technologies LLC
Job Description
Job Description:\n\nTitle: Manufacturing Operations Specialist IV Location: Santa Clara, CA 95054Duration: 6-8 Months Work ScheduleMonday–Friday, 6:00 AM–2:30 PM (onsite).Occasional evening or weekend work may be required.Overtime may be required based on production demand. Job Description:The Manufacturing Operations Specialist IV serves as the highest-level individual contributor within the Manufacturing Operations Specialist career path, providing senior leadership in manufacturing execution, production control, material readiness, manufacturing systems oversight, and operational performance. Acting as a strategic partner to Operations Management and a key liaison across Operations, Planning, Materials Management, Supply Chain, Engineering, Quality, Digital, and Manufacturing leadership, this role drives production readiness, work order execution, inventory coordination, operational reporting, and continuous improvement initiatives. Manufacturing Operations Specialist IV frequently leads Tier 2 production meetings, promotes cross-functional accountability, supports production scale-up activities, and ensures alignment of operational priorities with manufacturing schedules, build commitments, and business objectives. This role reports into the Surgical Robotics OTTAVATM Manufacturing organization. We are seeking a detail-oriented individual who thrives in a fast-paced environment and is eager to learn and grow. This position offers hands-on experience with innovative technology and opportunities for long-term career development. Key Responsibilities · Lead and own daily operational execution activities supporting manufacturing output, schedule attainment, production readiness, and operational objectives · Establish, communicate, and drive operational priorities to support production goals, build commitments, and manufacturing schedule adherence. · Independently create, release, prioritize, manage, and close manufacturing work orders, including standard production work orders, rework work orders, and related production control activities within MES, SAP/ERP, and other approved manufacturing systems. · Lead coordination of cross-functional activities between Manufacturing, Planning, Materials Management, Supply Chain, Engineering, Quality, Digital, and other support functions to ensure production readiness and issue resolution. · Lead daily Tier 1 production meetings and frequently lead or support Tier 2 production meetings, communicating production status, schedule risks, inventory readiness, operational constraints, and mitigation plans to leadership and stakeholders. · Drive accountability across functional organizations for action items impacting production execution, material availability, inventory accuracy, system readiness, and schedule adherence. · Present operational status, schedule risk assessments, production performance, inventory readiness, and mitigation plans to Manufacturing leadership and cross-functional stakeholders. · Serve as a recognized subject matter expert for MES transactions, SAP/ERP manufacturing processes, Power BI reporting, production control, inventory transactions, material flow processes, and approved manufacturing systems. · Support and execute critical manufacturing system activities, including Power BI updates, MES management, SAP support, peer review for containers, Quality Fixed-It tickets, rework work order management, and other production support activities · Review manufacturing transactions, production records, inventory movements, dashboards, and system documentation to ensure data integrity, accuracy, completeness, and compliance with Good Documentation Practices. · Support troubleshooting and resolution of manufacturing system issues, transaction discrepancies, inventory challenges, Quality system tickets, operational delays, and production process deviations. · Partner with Digital, Manufacturing Engineering, Operations, Quality, Planning, and Materials teams to optimize manufacturing workflows, improve system usability, and support manufacturing systems roadmaps. · Maintain, develop, and enhance operational dashboards, Power BI reports, build trackers, production metrics, and reporting tools to support accurate operational reporting, production visibility, and data-driven decision-making. · Coordinate material availability, kitting, staging, replenishment, inventory readiness, Kanban activities, and production support processes to enable uninterrupted manufacturing operations. · Perform and oversee inventory verification activities, cycle count reviews, inventory reconciliation, and material readiness processes while collaborating with Materials, Planning, Supply Chain, and Operations teams to improve inventory accuracy and material flow. · Identify operational bottlenecks, process inefficiencies, system gaps, and manufacturing execution risks while leading improvements that enhance operational performance, inventory management, production control, and manufacturing readiness. · Lead operational excellence and continuous improvement initiatives focused on improving efficiency, reducing production constraints, strengthening data accuracy, and standardizing manufacturing operations support processes. · Develop, standardize, and sustain operational processes, standard work, work instructions, reporting tools, system best practices, and training materials to support scalable manufacturing operations. · Analyze manufacturing performance data, operational trends, production metrics, and system outputs to recommend systemic improvements and support business decision-making. · Support production scale-up activities, future manufacturing capacity planning, and readiness initiatives aligned with business growth and operational strategy. · Train, mentor, and provide guidance to Manufacturing Operations Specialist I, II, and III personnel, promoting knowledge sharing, skill development, operational consistency, and team effectiveness. · Operate within a regulated manufacturing environment while maintaining compliance with ISO 13485, FDA QSR, GMP, GDP, and established company procedures. · Maintain organized records, system documentation, operational files, and work areas in accordance with safety, quality, compliance, and operational standards. · Demonstrate expert-level proficiency in manufacturing systems, inventory processes, production control, work order management, operational reporting, and cross-functional leadership while completing all required training and performance objectives. Qualifications Education: · High School diploma or equivalent with 5+ years of manufacturing operations, production control, materials management, supply chain, logistics, manufacturing systems, operations leadership, or related operational experience. Required: · Expert knowledge of manufacturing operations, production control, material flow concepts, inventory management, and manufacturing execution processes within a regulated manufacturing environment. · Expert working knowledge of Manufacturing Execution Systems, SAP/ERP platforms, inventory management systems, Power BI, reporting tools, and related operational technologies. · Demonstrated ability to lead daily operational execution, establish manufacturing priorities, coordinate production readiness, and support manufacturing schedules across multiple functional groups. · Proven ability to lead or support Tier 2 production meetings, communicate operational priorities, and drive cross-functional accountability for action-item closure. · Advanced proficiency in Microsoft Office applications, particularly Microsoft Excel, with strong ability to analyze, interpret, and communicate operational data, production metrics, and business-critical information. · Strong data analytics skills with experience using Power BI, dashboards, build trackers, or similar reporting tools to support operational visibility and business decision-making. · Advanced understanding of production control, inventory management, work order management, material readiness, manufacturing systems, and operational support processes. · Strong attention to detail with the ability to accurately manage system transactions, inventory records, production documentation, dashboards, and business-critical data. · Solid understanding of Good Manufacturing Practices, Good Documentation Practices, ISO 13485, FDA QSR, and regulated manufacturing environments. · Demonstrated ability to identify operational risks, investigate issues, perform root cause analysis, develop mitigation plans, and drive corrective actions to resolution. · Proven experience leading continuous improvement or operational excellence initiatives focused on manufacturing execution, inventory accuracy, system optimization, process standardization, or operational efficiency. · Strong written and verbal communication skills with the ability to effectively communicate production status, operational risks, inventory readiness, schedule impacts, and business updates to leadership and cross-functional stakeholders. · Strong executive-level communication and presentation skills with the ability to influence, align, and drive accountability across Manufacturing, Materials, Planning, Supply Chain, Quality, Engineering, Digital, and Operations teams. · Demonstrated ability to serve as a subject matter expert, mentor, trainer, or functional lead within a manufacturing, supply chain, or production control environment. Additional InformationThis job description is intended to outline the general nature and level of work performed. It is not an exhaustive list of all duties, responsibilities, or qualifications required. Employees may be assigned additional tasks aligned with business needs as per the individual’s capabilities. Preferred: · Associate degree in Supply Chain, Business, Manufacturing, Operations, Engineering Technology, or related field preferred. · Bachelor’s degree in Supply Chain, Business, Manufacturing, Operations, Engineering Technology, or related field beneficial but not required. · Experience using Learning Management Systems such as ComplianceWire, Manufacturing Execution Systems, SAP/ERP platforms, Airtable, Power BI, or similar business and operational systems. · Demonstrated experience supporting production planning coordination, operational reporting, inventory reconciliation, material readiness activities, manufacturing system administration, or production scale-up. · Experience partnering with Digital, Manufacturing Engineering, Operations, Planning, Materials, Supply Chain, and Quality teams to improve manufacturing workflows and system processes. · Experience leading process improvement initiatives focused on operational efficiency, inventory accuracy, manufacturing execution, workflow optimization, and production control standardization. · Previous experience serving as a senior subject matter expert, mentor, trainer, operational lead, or functional owner within a manufacturing or supply chain environment. · Lean Manufacturing, Six Sigma, continuous improvement, or operational excellence experience preferred.\n\nCompany Description:\n\nFusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.\n\nFusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.\n\nWe exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.
Company Description
Fusion was founded to set a new standard in Health care consulting and staffing Industry. Our company is made up of Technical experts, dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. We offer Engineering and FDA remediation services for the Pharmaceutical, Bulk Drug Manufacturing, Biotechnology, Medical Device and Heath Diagnostic industries. Fusion was founded on the promise that we would provide a superior staffing experience for our clients by delivering the highest trained individuals.\r\n\r\nFusion provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and FDA Remediation.\r\n\r\nWe exist to become the finest and most esteemed staffing company across USA, and we look forward to putting our talents to use to push your organization forward.
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