Manufacturing Engineering Manager

The Manufacturing Engineering Manager oversees the manufacturing engineering team and will be 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 and is expected to train and coach/mentor their team members, review and manage performance, and support career development for employees. They are expected to demonstrate expertise and technical leadership in cGMP compliance and be able to make decisions based on that experience.

How you will make an impact:

• Prioritize safety over all else and ensure that our processes are inherently safe.
• 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 utilize structured rapid problem solving techniques including A3, 8D, DMAIC, fishbone etc. to efficiently guide the team through thorough and rapid root-cause understandings.
• Develop, maintain and/or delegate 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.
• Translate high level project goals into a comprehensive set of working requirements working with both internal and external project stakeholders.
• 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.
• Interface with customers and manage the relationship to ensure crisp communication and alignment of objectives.
• Provide both high level technical and people leadership to project teams.
• Identify areas of cost reduction and manage the implementation of these types of programs.

To be successful in this role, you will need the following skills and 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.
• Practical experience with continuous improvement and problem-solving tools.
• Knowledge of statistics and probability.
• Demonstrated proficiency in supervision and motivating team members.
• Proven logic and decision making abilities, critical thinking skills.
• Exceptional project management and communication skills – written and verbal - are essential.
• High energy, drive, commitment, self-initiative and perseverance are required with a demonstrated track record of personal technical accomplishments.
• Medical device manufacturing experience.
• Working knowledge of Microsoft Office applications.