Manufacturing Engineering Manager

Responsibilities:

Guide the daily activities of the manufacturing engineering team, building team daily standard work, structured problem solving tools and guiding the team to thorough root-cause understanding.
Work cross-functionally with other functional groups to support and facilitate projects and tasks.
Heavily utilizes structured rapid problem solving techniques including A3, 8D, DMAIC, fishbone etc. to efficiently guide the team through thorough and rapid root-cause understandings.
Develops, maintains and/or delegates project plans for process improvement initiatives as a rolling, ongoing responsibility.
Identify and liaise with design authority resources to identify, drive and incorporate product design and specification changes to improve manufacturing process performance.
Manage outside resources providing new processes, equipment or contract support work.
Assist in the transfer and the production of new products from R&D into manufacturing. Design, develop, and test processes and equipment for production.
Responsible for improving yield and efficiency at the cell and plant level.
Identify, resource and manage opportunities for continuous improvement through use of tools such as PFMEA’s
Drive day to day project activity to achieve results including solving technical and other project challenges, managing resource conflicts, breaking down barriers, upholding high performance standards, and meeting commitments
Provide input on strategic direction of the group specifically around technology, capability and capital equipment
Continuously monitor and support manufacturing processes to optimize production flow, improve assembly methods including product quality, and expand capacity
Ensure compliance with our quality management system, especially relating to change management whether driven through continuous improvement activities or required changes

Skills & Experience:

BS or MS in mechanical engineering with 5-10 years’ experience in a cGMP environment
Minimum four (4) years leadership experience in a manufacturing environment, two (2) of which must be direct Engineering Management experience, preferably in a regulated environment.
Direct experience with complex electromechanical products with embedded software.
Knowledge of production practices and procedures in a cGMP environment.
Analytical problem-solving skills with the ability to troubleshoot complex problems and determine root causes.
Must have experience successfully managing projects from initial concept through design and release. Including the ability to execute and mentor others on scheduling, budget and utilization of project resources.
Working knowledge of product and process qualifications including IQ, OQ, and PQ.
Demonstrated proficiency in supervision and motivating team members.
Medical device manufacturing experience preferred.