ResponsibilitiesExpertise in vitro diagnostic (IVD) products, cGMP FDA regulatory compliance, and industry guidance initiatives such as MDDAPIndependently lead multiple custom automation system or new consumable injection molding projects simultaneouslyIndependently lead engineering functions such as: Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk managementAuthor documents to develop effective design and control plansEstablish validation requirements and develop IQ/OQ/PQ documents at suppliers for automation systems and/or injection molds with associated auxiliary equipment that may include leak testers, robots, separation systems, etc.Analyze advanced statistics to confirm or reject hypothesisAnalyze test results, provide recommendations, and author summary reportsIndependently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systemsGather requirements from key stakeholders to author project charters detailing the business need, deliverables, scope, capital and expense scenarios, resource requirements, implementation plan, and risk mitigation proposalsContinuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costsDevelop and/or implement continuous improvement ideas and participate in the strategic Operations plansLead the design transfer process as a core team representative from R&D to Operations, which may include automation, consumables, labeling, assembly, and supplier methodsManufacturing team lead for a newly acquired site or new supplier to gain process knowledge, which would support the transfer of consumables manufacturingLead complex cross-functional investigationsLead root cause analysis meetings and recommend corrective actions for non-conforming events or manufacturing concerns utilizing risk-based approach methodsLead others in ideation activities such as cause and effect analysis, process variables mapping, and pFMEAsActively manage asset maintenance with suppliers and monitor performance trendsGenerate innovative possibilities, perform feasibility studies, and determine the effectiveness of new design concepts or test methodsSupport the development of Supplier Agreements, Quality Agreements, and Operational FrameworksTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:QualificationsExperience with cGMP, manufacturing, machine operations, and data entry.Working knowledge of safety regulations, federal regulations and other regulations, e.g. QSR's, ISO, ISO 13485, etc. in a laboratory environment.Experience with automated and semi-automated equipment and processes.Detail oriented with strong verbal and written communication skills.Demonstrated ability to follow detailed directions in a manufacturing GMP environment.Lean manufacturing certification and experience strongly desired.Understanding of manufacturing systems, processes and equipment (documentation, compliance, Safety, change control, time and attendance, etc.).Solid understanding of the product and manufacturing processes.Establishes and maintains productive working relationshipsIdentifies problems, solves them, acts decisively, and shows good judgmentPlans and organizes work efficiently to manage time wisely. Prioritizes tasks within a dynamic and fast‑paced working environmentExhibits a high level of energy and is self‑motivated to sustain ambitious workCreates an open and accessible environment that encourages flow of informationWrites clearly and concisely. Composes information based on the specified audienceContinuously seeks new knowledge and rapidly assimilates it into the organizationEstablishes and models standards that guarantee exceptional qualityTakes action without being promptedMaintains an appropriate focus on outcomes and accomplishments. Persists until the objectives are achieved and conveys a sense of urgency when appropriateAwareness of their own behaviors and its impact on othersReadily offers opinions and takes action. Willing to challenge others appropriately when requiredEffective in flexing individual style to direct, collaborate, persuade, or motivate as the situation requiresDevelops expertise and shares functional knowledge with othersUnderstand formal and informal policies and operational frameworksShares resources, responds to requests from other departments, and engages with larger organizational objectivesEducationBA or BS degree, MA preferred. Field of study in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or Validation EngineeringLean Manufacturing and/or Six-Sigma Certification preferred but not requiredCertified Quality Engineering Certification preferred but not requiredExperience12+ years of Biotech / Medical Device / Pharmaceutical industry experienceHigh volume manufacturing experience in a regulated environmentHigh proficiency with MS Office, MS Project, and MS SharePointHigh proficiency with Minitab or other statistical analysis softwareWorking knowledge of manufacturing automation systems and design practicesWorking knowledge of cGMP, GAMP, ISO 13485, and FDA 21 CFR, Part 820#J-18808-Ljbffr