The Automation Engineering Manager will provide technical leadership in identifying and implementing state-of-the-art automation manufacturing technologies into a cleanroom production environment. The qualified candidate must be able to work independently and interface with an external team to design, develop, fabricate, implement and maintain automated manufacturing systems. The candidate must also demonstrate the ability to manage plans for fabrication, integration, qualification and validation of automated systems while providing aggressive leadership to achieve the automation goals of the company.
Principle Duties and Responsibilities:
Identify process automation opportunities to existing manual operations and manage the design, development, implementation, validation and maintenance of automated manufacturing systems. Areas of focus include adhesive dispensing, component mating and curing, force-feedback and vision systems, and translational and rotational parts movement.
Identify and institute state of the art manufacturing technologies and provide leadership, organization, coordination and planning of automation activities throughout production. Coordinate fabrication and purchasing activities with outside suppliers.
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.
Oversee project schedules, track costs, prepare status reports, conduct meetings, and communicate progress to management. Use of Microsoft Project desired.
Anticipate potential issues before they arise by relying on prior experience and gaining new industry knowledge.
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 beyond stated automation goals.
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.
Qualify, optimize and trend processes via IQ/OQ/PQ, Gage R&R Studies, Process Capability Studies, Designs of Experiments and Statistical Process Control.
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 automated manufacture, test, and inspection as appropriate.
Skills/Requirements
Job Qualifications:
BS in engineering required, MS desired with a minimum of 10 years of related work experience desired. A minimum of 6 years of experience designing, developing and implementing automated manufacturing systems is required. Medical device experience preferred.
Intimate knowledge of FDA QSR and ISO regulations required.
Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives.
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.
