You will manage the supervisors, team leaders, and assemblers who make the Impella, the world's smallest heart pump. You also much meet objectives in the areas of People, Safety, Environment, Quality, Delivery, and Cost while complying with all internal and as external policies and procedures. Promote and drive Lean and Continuous Improvement as part of the daily work activities. Manage the manufacturing operations by planning production schedules, materials requirements, budgeting, and staffing needs.
Establish a culture of excellence in execution, continuous improvement, and communication within production facilities. Demonstrat an ability to think globally.
You will hire, train, and supervise assembly and other manufacturing operations staff, as well as intermediate supervisors and team leaders.
Develop training programs to facilitate cross training of manufacturing personnel, employee development, and quality systems compliance.
Perform general management duties, evaluate training needs, performance appraisals, timekeeping, consistent application of organizational policies, development, promotions, and terminations
Ensure compliance with ISO13485, GMP,FDA, and OSHA regulations
You will assure timely delivery of product per agreed-to build plan
Monitor work, alter schedules to meet unforeseen conditions, control flow of work to ensure maximum use of available capacity and effective use of labor, tools and equipment
Provide prompt problem solving for key issues, driving through from root cause identification, containment, problem resolution, and ensuring repeat issues are avoided
Act as a team role model and change agent. Positively lead and influence team members to partner together to achieve individual
Skills/Requirements
BS, degree in engineering or technical field is required
8 years of manufacturing experience; Medical device/clean room experience required
Experience managing compliance associated with quality, regulatory, and safety policies
Strong Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives. Black Belt required
Experience with process and equipment changes in a FDA regulated environment (IQ/OQ/PQ/PPQ) required
Ability to provide positive and constructive feedback, coach/mentor, and develop individuals
Knowledge of manufacturing operational systems, best practices, processes, and technology
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
Must be willing and able to work flexible shifts to meet business and employee needs
Highly proficient in Microsoft Office Suiteand working knowledge of SAP desired
Model the Abiomed values and culture to be an Ambassador for Abiomed within and outside the company (#LI-LG1)
