Manufacturing Engineering Manager
1 week ago
The Manufacturing Engineering Manager will oversee a team of manufacturing engineers and be responsible for driving structured continuous improvement activities to confirmed savings. They are expected to demonstrate expertise and technical leadership in cGMP compliance and be able to make decisions based on that experience. Is expected to train and coach/mentor their team members, review and manage performance, and support career development for employees.
How you will be successful:- Prioritizing safety over all else and ensure that our processes are inherently safe.
- Leading your engineering team in manufacturing life changing medical devices by using structured problem solving techniques, following correct documentation practices, and completing projects on-time.
- Translating high level project goals into a comprehensive set of working requirements, working with both internal and external project stakeholders.
- Proactively working to improve yield and efficiency for equipment lines. Identify critical machine components and create maintenance plans around them.
- Implementing training and development plans for your engineering team.
- Engaging your engineering team to work cross-functionally with other functional groups and R&D teams.
- Driving opportunities for continuous improvement through use of tools such as PFMEA’s.
- Providing input on strategic direction of the group specifically around technology, capability and capital equipment.
- Leading the team to monitor manufacturing processes to optimize production flow, improve assembly methods including product quality, and expand capacity.
- Managing product master data, engineering change requests and change orders (ECR/ECO) in our PLM system.
- Ensuring compliance with our quality management system, especially relating to change management whether driven through continuous improvement activities or required changes.
- Interfacing with customers and manage relationships to ensure crisp communication and alignment of objectives.
- Providing both high level technical and people leadership to project teams.
- 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.
- Confirmed usage of analytical problem-solving skills with the ability to troubleshoot complex problems and determine root causes (Six Sigma, Shainin Red X, 8D, A3, 5-Why, etc).
- 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.
- Capital equipment purchasing, sourcing, validation, and OEE improvement.
- Working knowledge of product and process qualifications including IQ, OQ, and PQ.
- 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 preferred.
- Working knowledge of Microsoft Office applications.
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