As a member of the Production Operations team, the Lead Production Operator will be responsible for leading all production activities for designated product line(s). This individual will train Production Operators on assembly processes, techniques and skills needed to perform assembly of ACIST Medical devices and other production tasks, ensure that Standard Operation Procedures (SOP’s) and Work Instructions (WI’s) are followed and meet quality requirements and standards, provide day-to-day workflow guidance to ensure daily goals are met, and assist with documentation updates to management as necessary.  

 

 

• Learn and understand a wide variety of production job duties at a high level of detail and maintain that knowledge by performing those duties when you are not training.  

• Coordinate and deliver employee training to production operators ensuring that procedures are followed and meet all quality requirements. Scope includes new-hire training, temporary employee training and on-going employee cross-training. Provide ongoing feedback and coaching to employees during training to maximize their learning

• Coach and train employees to achieve maximum quality and productivity and ensure employees are following procedures. Escalate non-compliance issues as needed to management. 

• Report on progress of employees under guidance during training periods to management.  Conduct routine training audits to identify training gaps. Conduct re-training to correct deficiencies. 

• Create, implement and maintain a training matrix for the production lines. Integrate training plans within the Learning Management System (LMS)

• Complete all training documentation requirements timely and accurately including post-training follow-up.

• Assist in developing and maintaining training metrics to drive performance improvements.  

• Assist in collecting and providing training key performance indicators (KPI's).  

• Observe and audit work to make proposed changes to processes or documentation that enhance production while positively contributing to safety, quality, cost, etc. 

• Actively seek to improve documented procedures including but not limited to standard operating procedures and work instructions and provide suggestions for improvement and/or corrections to Manufacturing Engineer and management.

• Stay current with changes and enhancements made to existing processes and products to ensure revisions are accurately presented during training.

• Interact directly with manufacturing engineering and production personnel as well as cross-functional personnel to help identify and solve problems impacting production processes and training

• Identify gaps in training curriculum, obtains approval for resolution, and take action to correct.

 

• Become the SME on your designated production lines.

• Able to communicate, delegate, encourage, and motivate line workers to meet production deadlines and goals in positive and creative manner.

• Encourage teamwork, initiative and sets good example.

• Report line down time and non-conforming material to management.

• Assist with all tasks related to production including but not limited to performing assembly and test duties

• Monitor and ensure there are no stockouts of sub-assemblies

• Maintain a clean and organized work area.

• Use basic problem-solving skills to ensure stable operation of the work cell.

• Report problems or concerns with quality, processes, equipment, materials to Production Supervisor.

• Update production metrics and facilitate regular team communication.

Perform timely transactions online utilizing ERP/MRP system

• Understand and comply with ACIST Medical Quality Policy, ESD precautions, and OSHA guidelines as applicable

• Become knowledgeable with SAP and help production operators with inventory and processing questions.

• Create and close Production Orders for Production lines.

• Maintain quarterly (Point Of Use) inventory for designated area

• Assist Team Lead with work activities in designated area’s

• High School diploma or equivalent

• 3 - 5 years electro/mechanical medical operations experience or advanced degree in operations

• 2+ years experience in team lead or similar role

• Knowledge and ability to use of mechanical assembly tools 

• Advanced level of computer proficiency including MS Word, Excel, Outlook, and MRP Systems and database systems

• Knowledge of Good Manufacturing Procedures (GMP’s), ISO regulations, and Quality Systems as it pertains to hardware manufacturing at Medical Device Manufacturers

• Demonstrated ability to follow manufacturing processes including problem solving

• The ability to maintain accurate documentation (e.g., record trace ability information onto routers, and transact materials online)

• Ability to work effectively in a team environment and contribute to maintaining positive interpersonal relationships and foster cooperation within and outside the department

• The physical ability to lift and package assemblies up to 45 lbs

• Ability to handle multiple tasks simultaneously

• Ability to communicate in a clear and understandable format.

• Deal with constructive criticism and be able to use that in learning opportunity. 

 

• 4-7 years electro/mechanical medical device operations experience or advanced degree in Operations management

• Demonstrated experience or proven ability utilizing measurement equipment (i.e. DMM, caliper, micrometer, oscilloscope)

• Sense of urgency and self-motivation