Cogmedix

Job Description

The responsibility of this position is to lead and coordinate operations staff activities that are required to meet or exceed our customers’ expectations and internal objectives for safety, quality, delivery, and cost. This is to be accomplished by developing and motivating our caring associates, and ensuring compliance and adherence to processes, which are to be optimized using Continuous Improvement methods. This role is a professional leader that holds the team accountable to company goals, in a manner that fosters respect, communication, cooperation, and collaboration. The Senior Operations Manager has ultimate responsibility for Associate Production Managers and their direct reports (Assembly Technicians, Test Technicians, Inspectors, and Supply Chain Associates) and collaborates with all other departments to achieve goals.

Responsibilities

  • Ensure that safe techniques and tools are being utilized. Ensure that associates have proper training to perform their roles safely while they adhere to outlined safety policies and procedures. Ensure timely resolution of any unsafe practices or conditions.
  • Foster a culture of compliance, promoting the Cogmedix motto “Cogmedix = Compliance“ in all aspects of operations.
  • Maintain cGMP’s and compliance to the Cogmedix Quality System.
  • Collaborate with the Quality team to ensure all direct report associates have been trained properly and have appropriate training records on file.
  • Identify, report, and propose resolutions to any quality or compliance problems or discrepancies.
  • Identify those requirements which would affect quality and ensure the necessary guidelines are documented in procedures, work instructions, and training plans.
  • Monitor and reduce workmanship nonconformities.
  • Ensure all written Work Instructions and procedures are followed accurately and compliantly.
  • Responsible for all aspects of operations staffing, including hiring, training, and performance management.
  • Perform capacity planning to determine staffing levels required to meet schedules across all customers.
  • Encourage associates to provide ideas for continuous improvement through the EOED (Every One, Every Day) program, or directly to their supervisors.
  • Expand, develop, and measure the skills of the associates through cross training and other methodologies to increase their capabilities and value to Cogmedix and our customers.
  • Mentor, coach, and develop current and future operations leadership.
  • Utilize appropriate strategic and tactical planning and communication techniques to ensure all associates are clear on daily and weekly production goals and expectations.
  • Continuously monitor and improve labor utilization and productivity.
  • Utilize ERP for various material analyses, production-planning activities, OTD, and work order execution.
  • Use analytical skills to assess department needs to develop short and long-term strategies for improvement.
  • Champion Continuous Improvement program implementation, maintenance and associate participation.
  • Implement and coach lean manufacturing tactics to continuously reduce costs, inventory, and lead-times while improving product quality and process efficiency.
  • Communicate directly and effectively with customers and suppliers as needed.
  • Collaborate with other colleagues on quotation activities, materials flow, MRB, supplier quality, process validations, corrective and preventive action, and other activities as needed.
  • Engage with Supply Chain and Finance organizations to oversee processes, conditions, and methods to ensure inventory integrity, accuracy, organization, storage, and security.
  • Ensure planned maintenance, calibration, and replacement of equipment used in operating processes, such as vehicles, gauges, tools, testers, and machinery, are carried out to maintain compliance, safety, and optimal conditions.
  • Other responsibilities and projects as directed.

Essential Requirements

  • Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.
  • Recognized as a leader who is decisive, has strong organizational skills, attention to detail, and the ability to prioritize multiple functions to meet required deadlines and delight customers.
  • Superior customer service internal and external attitude required.
  • Strong ability to manage, lead, mentor and inspire our caring associates required.
  • A demonstrated commitment to company values.
  • College degree, preferably in an operations or engineering discipline. Applicable professional experience may be considered in lieu of certain educational requirements.
  • 10+ years’ experience in managing and leading manufacturing and warehousing teams in processing complex electro-mechanical and optical assemblies and components.
  • Certification as a Six Sigma Black/Green Belt, and/or Lean expertise required.
  • Operations management software (ERP/MRP/MES/WMS) experience required. Epicor preferred.
  • Manufacturing operations experience in a medical device environment desirable.
  • Working knowledge of cGMP, FDA QSR, ISO 13485, QOP’s, work rules and safety guidelines highly desirable.
  • Must be able to read, write, and comprehend English.
  • Ability to read and understand detailed instructions, manufacturing procedures, and drawings.
  • Knowledge of assembly and test methods.
  • Strong knowledge of Microsoft Word, Excel, PowerPoint.
  • Must be able to lift up to 30 lbs.
  • Stand for prolonged periods of time.