Manufacturing Engineering Manager

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.