Job Title: Senior Manufacturing Engineer Location: Newark, DE (onsite) Duration: 5 Months on W2 contract (High Possible for Extension)

Job 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.

Description: Summary of Duties and 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.

· 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.

· Extensive travel will be required up to 70% during critical times, including extended presence at contract manufacturer Midwestern US.

Qualifications:

· 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.

Education:

· B.S. Engineering preferably in Mechanical, Electro-Mechanical, Electrical, or Industrial Engineering