.Summary of PositionThis role will be responsible for the supervision of production and engineering staff.
This staff will be involved in the execution of established work instructions and SOP's to perform assembly of medical products using manual processes as well as semi-automated manufacturing machines.
This position will also oversee processes related to equipment maintenance management, continuous improvement, cleaning/hygiene procedures, overall facility safety, and chemical control.
This position will also oversee the training of manufacturing department employees and ensure documentation is completed for training.
This position must ensure procedures are in place and followed to meet ISO 13485 and FDA guidelines for compliance.
This is a hands-on leadership role, with the responsibility to provide oversight, supervision, and development employees in a team environment.Primary Responsibilities- Supervise manufacturing department in the execution of established work instructions, cleaning and hygiene procedures, and equipment maintenance.- Develop and maintain a positive team-based working environment in which the team takes pride in exceeding plans and quality standards.- Ensure all personnel is properly trained to perform their job, ensuring the training is well documented.- Oversee and assist with all personnel safety aspects of the manufacturing department to ensure safe work practices are adhered to.- Oversee and assist with all equipment maintenance requirements to ensure a safe work environment and a high overall equipment effectiveness.- Work with other departments to meet relevant company goals and objectives.- Ensure compliance with ISO 13485 and FDA/QSR regulations.- Write and maintain team goals, objectives, and reviews.- Create and drive metrics for quality and build plan, FPY, line capacity, tact times, equipment maintenance etc.- Establish and manage continuous improvement system for the manufacturing department.- Drive new product introduction to full production- Compliance with all personnel policies- Frequent execution of lifting supplies and parts weighing up to 50lbs.- Provide cross-functional leadership to set and maintain the proper rigor for transfers of new products into manufacturing.- Ensure problems within manufacturing are identified, prioritized, and resolved in a timely manner.- Prepare manufacturing proposals, cost estimates and capital appropriation requests.- Represent Manufacturing during new product design phases.- Setting and realizing in-process quality and identified functional objective goals.- Improving manufacturing related SOP's and generating new ones as required.- Manage improvement projects and project budgets.- Ensure that goals and objectives are clearly communicated and executed to plan.- Identifies opportunities to improve processes, e.G