Senior Manufacturing Engineer

Position Title:

Senior Manufacturing Engineer Work Location:

600 Technology Drive, Newark, DE 19702

Assignment Duration:

7.5 Months + 1st shift - 6 AM - 3

PM Position Summary:

The Manufacturing Engineer 3 Senior Manufacturing Engineer provides a key technical interface to a critical contract manufacturing relationship. The contract manufacturer provides a system consisting of electromechanical capital equipment as well as high-volume sterile disposables.

Key Responsibilities:

Create and execute validation plans, including IQ of process equipment and OQ and or PQ of manufacturing processes. Lead manufacturing implementation of sustaining design initiatives. Detect, conceptualize, and execute improvement opportunities using a series of Lean and related tools and methodologies. Distill complex technical situations into meaningful summaries that are digestible by various stakeholders. Lead troubleshooting exercises to quickly get to solutions. Create and revise essential documents such as process flowcharts, PFMEA, and Process Control plans. Practice LEAN techniques and be able to facilitate lean kaizens. Interface with contract manufacturing staff and management to ensure that plans are followed and risks are mitigated. Work effectively with other functions such as research and development, Procurement, Design Quality Assurance, Regulatory Affairs, and Field Service in completion of duties and communication of relevant information. Interface with suppliers and Quality Engineering to resolve supplier quality issues. Monitor quality reports and field performance of assigned product line, identify trends, investigate problems and implement corrective actions. Actively supports and adheres to the Quality Policy and Quality System procedures. Other duties relating to above as may be required.

Qualification & Experience:

Medical device industry experience Extensive validation experience, including employment of sound statistical approach and authorship of solid protocols and or reports. Advanced inter-personal skills, communication and emotional awareness is key to be successful in this role. Quick learner, driven and not afraid to experiment. Ability to manage projects and lead and coordinate cross-functional teams. Thorough understanding of Lean Manufacturing principles required 5S, Value Stream Mapping, Kanban, SMED, GEMBA mindset, KPI development and management. Good understanding of product lifecycle management PLM applications such as AGILE and ERP systems such as ORACLE, SAP or

BAAN. ORACLE

is preferred. Experience with LABVIEW highly preferred. Experience with computer-aided design software required, Solid works preferred. B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering 7or more years' experience in Manufacturing and or Manufacturing Engineering with working knowledge of electro-mechanical sub-assemblies.