The Manufacturing Engineering Manager will oversee the design, development, 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.
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.
Suggest and lead product-independent technical improvement projects, estimating resource requirements, return on investment and time to implement.
Support global new product introduction, 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.
Ability to work in cross-functional teams that span global operations. Highly effective communicator of technical status and issues required. Must enjoy team approach over individual contributions.
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 prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with the Operations, Product Development and Quality Assurance organizations.
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.
Identify and execute process validations including generation of plans, protocols and reports.
Plan and schedule projects, estimating required timing, resources and budgets which are consistent with corporate objectives. Use of Microsoft Project desired.
Regularly report on project status, schedule progress and key project metrics through scorecard presentations, action items and meeting minutes, and manufacturing readiness reviews with program and operations management.
Qualify, optimize and trend processes via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies, Designs of Experiments and Statistical Process Control.
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.
Work with product development staff to ensure that products under development are designed for manufacture, test, and inspection as appropriate.
Skills/Requirements
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.
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.
