The Manufacturing Engineering Manager oversees the manufacturing engineering team and is responsible for leading technical support activities for daily production challenges, driving continuous improvement, new product introductions, and implementing or improving existing systems to enhance our operations under current Good Manufacturing Practice (cGMP) conditions. The manager is expected to exemplify safety and compliance, train and mentor team members, review performance, and support career development. They should demonstrate expertise in cGMP compliance and make informed decisions based on their experience.
How you will make an impact:
* Prioritize safety above all and ensure processes are inherently safe.
* Guide daily activities of the manufacturing engineering team, developing standard work, problem-solving tools, and root-cause analysis.
* Collaborate with cross-functional teams to support projects and tasks.
* Utilize structured problem-solving techniques such as A3, 8D, DMAIC, and fishbone diagrams for root-cause analysis.
* Develop and maintain project plans for process improvements.
* Liaise with design authorities to incorporate product design and specification changes to improve manufacturing performance.
* Manage external resources providing new processes, equipment, or support.
* Assist in transferring and producing new products from R&D, designing and testing processes and equipment.
* Translate high-level project goals into detailed requirements with stakeholders.
* Improve yield and efficiency at the cell and plant levels.
* Identify and manage continuous improvement opportunities using tools like PFMEAs.
* Drive project activities to meet goals, resolve technical challenges, manage resources, and uphold standards.
* Contribute to strategic decisions regarding technology, capabilities, and capital equipment.
* Monitor and optimize manufacturing processes for flow, quality, and capacity expansion.
* Ensure compliance with quality management systems, especially change management.
* Manage customer relationships and communication.
* Provide technical and leadership guidance to project teams.
* Identify cost reduction opportunities and oversee their implementation.
Required skills and experience:
* BS or MS in mechanical engineering with 5-10 years in a cGMP environment.
* At least four (4) years of leadership experience in manufacturing, including two (2) years in direct engineering management, preferably in a regulated setting.
* Experience with complex electromechanical products with embedded software.
* Knowledge of production practices in a cGMP environment.
* Strong analytical and troubleshooting skills.
* Experience managing projects from concept to release, including scheduling, budgeting, and resource management.
* Knowledge of product and process qualifications (IQ, OQ, PQ).
* Experience with continuous improvement and problem-solving tools.
* Knowledge of statistics and probability.
* Proven leadership and team motivation skills.
* Strong decision-making and critical thinking skills.
* Excellent project management and communication skills.
* High energy, drive, perseverance, and a track record of technical accomplishments.
* Experience in medical device manufacturing.
* Proficiency in Microsoft Office applications.
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