DirecciónPlay a pivotal role in ensuring the successful execution of projects for engineering, maintenance functions including methods and time studies, process validations, maintaining product quality, developing new automation or improving existing machinery, preventative maintenance programs, sales and marketing support, production manufacturing efficiencies and the Operator Incentive Program.
- Manage Methods and Time Studies Program for all products and routing operations.
- Lead and manage team of engineers responsible for development and production of medical devices. Foster a culture of innovation, collaboration, and knowledge sharing within the engineering team.
- Provide technical guidance and expertise to engineers and project teams throughout product life cycle.
- Develop and implement engineering strategies, goals, and objectives aligned with the company’s mission and quality standards.
- Manage the Operator Incentive Program, including the establishing and implementing of new labor and machine rates.
- Perform validations, including installation validations, process validations, maintenance procedures, and preventative maintenance procedures.
- Develop and qualify new products.
- Develop new automation and implement improvements to existing automation.
- Responsible for the development, updating and maintaining of the Bill of Materials, and routing for new and revised products.
- Responsible for the control and implementation of all Engineering Change Orders (ECO’s), and the related documentation.
- Responsible for the development and implementation of the Device History Record routing operations and material requirements for the assembly of all products.
- Responsible for the development and updating of specifications for the components used in the manufacture of I.V. Sets, OEM medical devices, and chemotherapy protective equipment.
- Manage project timeline, budgets, and resources to ensure timely and cost-effective completion of engineering projects.
- Collaborate with cross-functional teams, including marketing, quality, regulatory affairs, and manufacturing to ensure effective product development and production process.
- Manage all maintenance, facility and cleaning operations, as well as ensure that the preventative maintenance program is effective and followed.
- Minimum two to five years in high volume assembly or manufacturing environment for the Health Care Industry.
- Knowledge of Methods and Time Studies (MTS), process validations, FDA Guidelines and Good Manufacturing Practices (GMP’s), ISO, automation, product development and qualifications, CAD and continuous improvement tools (SPC,TQM, CPI, JIT, etc.).
- Knowledge of manufacturing operations, maintenance and preventative maintenance programs, and sales and marketing support.
- Supervisory experience is preferred.
- Excellent interpersonal, written and oral communication skills.
- Knowledge of current versions of ISO 13485 as necessary.
- Proficient in writing and speaking English and Spanish
Tipo de puesto: Tiempo completo
Salario: $2,495.62 - $7,373.86 a la semana
Horario:
- Lunes a viernes
- Turno de 10 horas
- Turno matutino
Prestaciones:
- Estacionamiento de la empresa
Idioma:
- Inglés (Obligatorio)
Disponibilidad para viajar:
- 50 % (Obligatorio)
Lugar de trabajo: Empleo presencial
