Senior Manufacturing Engineer

Responsibilities

• Expertise in vitro diagnostic (IVD) products, cGMP FDA regulatory compliance, and industry guidance initiatives such as MDDAP
• Independently lead multiple custom automation system or new consumable injection molding projects simultaneously
• Independently lead engineering functions such as:
  Design Reviews, Measurement Systems Analysis, Design of Experiments, feasibility studies, process development, acceptance testing, and risk management
• Author documents to develop effective design and control plans
• Establish 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 hypothesis
• Analyze test results, provide recommendations, and author summary reports
• Independently lead the creation of RFQ/URS documentation for injection molds and/or consumables automation systems
• Gather 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 proposals
• Continuously improve internal and external supplier processes to reduce the time to market, enhance product quality, and decrease costs
• Develop and/or implement continuous improvement ideas and participate in the strategic Operations plans
• Lead the design transfer process as a core team representative from R&D to Operations, which may include automation, consumables, labeling, assembly, and supplier methods
• Manufacturing team lead for a newly acquired site or new supplier to gain process knowledge, which would support the transfer of consumables manufacturing
• Lead complex cross-functional investigations
• Lead root cause analysis meetings and recommend corrective actions for non-conforming events or manufacturing concerns utilizing risk-based approach methods
• Lead others in ideation activities such as cause and effect analysis, process variables mapping, and pFMEAs
• Actively manage asset maintenance with suppliers and monitor performance trends
• Generate innovative possibilities, perform feasibility studies, and determine the effectiveness of new design concepts or test methods
• Support the development of Supplier Agreements, Quality Agreements, and Operational Frameworks

To 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:

• Experience 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 relationships
• Identifies problems, solves them, acts decisively, and shows good judgment
• Plans and organizes work efficiently to manage time wisely. Prioritizes tasks within a dynamic and fast‑paced working environment
• Exhibits a high level of energy and is self‑motivated to sustain ambitious work
• Creates an open and accessible environment that encourages flow of information
• Writes clearly and concisely. Composes information based on the specified audience
• Continuously seeks new knowledge and rapidly assimilates it into the organization
• Establishes and models standards that guarantee exceptional quality
• Takes action without being prompted
• Maintains an appropriate focus on outcomes and accomplishments. Persists until the objectives are achieved and conveys a sense of urgency when appropriate
• Awaren…