Description

Job Summary:

• 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.

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.
• 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.

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 computer-aided design software required, Solid works preferred.

Education

• B.S. Engineering preferably inEngineering

Physical Demands

• Sit; use hands to finger, handle or feel objects, tools, or controls. Repetitive hand motion.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting and or moving and carrying products weighing up to 50 pounds.
• Exposure to moving mechanical parts, vibration and or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• May work with or around high voltage and radiation generating equipment.
• Safety shoes with impact and compression protection must be worn in designated areas.