The Production Engineering Manager will oversee the technical support of production operations, improvement and validation of manufacturing processes, tooling, and fixtures in order to meet daily production schedules, while mentoring team members, reducing defects and enhancing productivity and product quality. Role will focus on US production operations but will need to be engaged with European operations to ensure consistent processes and practices. 

Principle Duties and Responsibilities:

• Mentor/coach and develop skills of direct reports including planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Mentor on areas of engineering expertise; Be an agent of change, constantly moving the team towards improvements in technical skills and system knowledge.
• Anticipate potential issues before they arise by relying on prior experience and gaining new industry knowledge.
• Qualify, optimize and trend processes via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies, Designs of Experiments and Statistical Process Control.
• Establish and maintain key metrics including, but not limited to: yield, equipment/fixture uptime, and product quality
• Suggest and lead technical improvement projects, estimating resource requirements, return on investment and time to implement.
• Manage resources for production floor support and production transfer efforts through recurring meeting coordination/attendance and international travel (10%-25% required) between facilities, ensuring corporate objectives are met in a timely manner.
• Use Lean and Six Sigma tools to analyze process trend data or communicate issues based upon data driven approach.  Must identify opportunities for process and yield improvement projects. 
• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.  Intimate knowledge of FDA QSR and ISO regulations required.
• Develop and maintain process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
• Plan and schedule projects, estimating required timing, resources and budgets which are consistent with corporate objectives.  Use of Microsoft Project desired.
• Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions, audit findings. Address WIP and Incoming MRB in a timely manner.
• Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments as related to Abiomed products. 

Job Qualifications:

• BS in engineering required, MBA or MS desired with a minimum of 10 years of related work experience desired. Medical device experience preferred.
• Intimate knowledge of FDA QSR and ISO regulations required.
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives.  Black Belt preferred.
• Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team
• Ability to exercise judgment in selecting, methods, techniques, and evaluation criteria for obtaining results.
• International  travel (10%-25%) required
• Must be proficient in Microsoft Office Suite. Working knowledge of SAP desired.