Job Description
The Manufacturing Engineering Manager oversees the manufacturing engineering team and is responsible for leading technical support activities for daily production challenges, driving continuous improvement activities, new product introductions, and leading the implementation and/or improvement of existing systems to increase the maturity of our operation under current Good Manufacturing Practice (cGMP) conditions. The Manufacturing Engineering Manager is expected to set the example of safety and compliance for their teams, train and coach/mentor team members, review and manage performance, and support career development for employees. They should demonstrate expertise and technical leadership in cGMP compliance and be able to make informed decisions based on that 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, build standard work, utilize structured problem-solving tools, and guide the team to thorough root-cause understanding.
- Collaborate cross-functionally with other groups to support projects and tasks.
- Utilize structured rapid problem-solving techniques such as A3, 8D, DMAIC, fishbone diagrams to guide the team efficiently through root-cause analysis.
- Develop, maintain, and delegate project plans for process improvement initiatives.
- Identify and coordinate with design authority resources to incorporate product design and specification changes to enhance manufacturing performance.
- Manage external resources providing new processes, equipment, or contract support.
- Assist in transferring and manufacturing new products from R&D, designing, developing, and testing processes and equipment.
- Translate high-level project goals into detailed working requirements, collaborating with internal and external stakeholders.
- Improve yield and efficiency at the cell and plant levels.
- Identify, resource, and manage continuous improvement opportunities using tools like PFMEAs.
- Drive daily project activities to achieve results, solve technical challenges, manage resources, and uphold high standards.
- Contribute to the strategic direction regarding technology, capabilities, and capital equipment.
- Monitor and support manufacturing processes to optimize flow, improve assembly methods, and expand capacity.
- Ensure compliance with quality management systems, especially related to change management.
- Interface with customers to ensure clear communication and alignment of objectives.
- Provide technical and leadership guidance to project teams.
- Identify cost reduction opportunities and oversee their implementation.
Qualifications and Experience:
- BSc or MSc 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 environment.
- Experience with complex electromechanical products with embedded software.
- Knowledge of production practices in a cGMP setting.
- Strong analytical and troubleshooting skills with a focus on root cause analysis.
- Experience managing projects from concept to release, including scheduling, budgeting, and resource management.
- Knowledge of product and process qualifications (IQ, OQ, PQ).
- Practical experience with continuous improvement and problem-solving tools.
- Understanding of statistics and probability.
- Proven leadership and motivation skills.
- Strong decision-making, critical thinking, and communication skills.
- High energy, initiative, perseverance, and a record of technical accomplishments.
- Experience in medical device manufacturing.
- Proficiency in Microsoft Office applications.
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