Sr. Manager, Operations, CADI

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Overview

The Senior Manager, Operations is responsible for leading the Cardiac Assist Disposables (CADI) Manufacturing Operations, planning process, and Quality Control Receiving Inspection in the Wayne, NJ and Fairfield, NJ locations.  This position ensures the timely execution of the suppling the Sales and Service Units (SSU) with service and finished goods from our Intra-Aortic Balloon portfolio. The Senior Manager is responsible for on-going efforts to improve department efficiency and reduce operational costs while maintain or improving quality standards.

 

Job Responsibilities and Essential Duties

• Manage manufacturing operations of the Cardia Assist Disposables and Post-Quality-Packing manufacturing areas to meet planned production schedules.  Work with Shipping, Quality and Planning Departments to coordinate production completion with order demand.  Prepare manpower projections and capacity studies by measuring production performance against stated schedules, monitor and meet efficiency goals and manage changes to workplace. 
  • Production planning – manages the production planning for disposable business
  • PQP Shipping – manage the shipping for the balloon process
  • CADI Receiving Inspection – manage the incoming and in-process inspections and team (comprised of a manager, inspectors and engineers).
• Assure all ISO/FDA/GMP requirements are in compliance through training, proper documentation, audits of manufacturing operations and improvements of manufacturing process.  Ensure all manufacturing documentation are current and maintain required traceability.  
• Implement changes to production operations based on Manufacturing Engineering and/or R&D designs and improvements, equipment implementation or other changes to current operations. 
• Identify and develop plans to control and lower production costs, including labor, materials, and overtime. Coordinate activities with Manufacturing Engineering, Quality Assurance and Maintenance to achieve these goals. 
• Develop supervisors to take a more active role in identifying and solving operational problems, process improvements and scrap reduction. Provide guidance to Supervisors on employee discipline and other HR processes assuring consistent implementation of company policies and guidelines.
• Work on cross-functional teams and works closely with Manufacturing Engineering, R&D and Quality Control in their support of Production operations.  Lead effort in solving Operations problems, manage first analysis of failure data from floor and field for problem solving and quality improvements.
• Work closely with Sustaining Engineering and R&D to support Operations Service and Purchasing Departments. 
• Provide support in completing engineering projects such as enhancements to existing product lines or to implement cost reductions or design changes. 
• Evaluate customer complaints and solve corresponding problems as required.
• Provide oversight to the cycle counting effort to execute and investigate variances to eliminate re-occurring problems.
• Prepare budgets for financial planning
• Assure compliance with all safety regulations set forth by the company.

 

Minimum Requirements

• 10-15 years of experience in manufacturing and/or engineering management.
• Bachelor’s degree preferred or equivalent combination of experience and education.
• Minimum of 5 years managerial experience required.
• Must have work experience in medical device field with thorough knowledge of ISO/FDA/GMP requirements. 
• Understanding of clean room practices and batch manufacturing
• Electronics background a plus

 

Required Knowledge, Skills, and Abilities

 

• Evaluate utilization of manufacturing labor daily to meet produc