Sr. Manager, Operations, CADI

Getinge•Wayne, NJ

10d•$165,000 - $175,000

About The Position

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.

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
Strong leadership skills required. Strong interpersonal skills to interact with people at all levels of the organization in either one-on-one or group settings
Problem solving skills to lead effort of engineering groups in solving manufacturing and/or design issues
Organizational skills to coordinate efforts of Engineering and Production Departments to achieve common goals
Computer literacy and ability to use electronic tools for inventory management, production schedule, device history trace ability and prints/drawings/procedures
Ability to read prints, drawings, and schematics
Strong organizational skills necessary to handle a variety of concurrent tasks.
Strong problem-solving skills needed.
Interpersonal management and leadership skills required for training for developing and leading all members of manufacturing organization

Nice To Haves

Electronics background a plus

Responsibilities

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.
Evaluate utilization of manufacturing labor daily to meet production goals and assign personnel, as necessary, to meet objectives
Approve employee performance and determine salaries, increases, promotions and, if appropriate, performance improvement actions. Work with Human Resources to implement all decisions
Evaluate data and work with engineering groups to solve product problems and drive improvement.
Evaluate budgets and expenditures and make necessary changes to meet budgets guidelines