JOB SUMMARY:
Engineering Manager will manage one engineering team, and be responsible for providing technical support to, both NPI and MP products, with a focus on: the development of new processes and features, optimizing existing processes, implementing process improvements, supporting customer complaints/technical investigations and acts as a lead for Risk Assessments & Gap analysis.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
•Responsible for establishing and maintaining robust, stable, and capable manufacturing processes and validation processes that meet or exceed quality expectations.
•Lead communication with customers, driving the NPI progress and MP key activities.
•Lead problem solving, troubleshooting activities and defining the root cause to reduce variation in processes.
•Drive the optimization of manufacturing process and engineering related documentation.
•Support technical investigations associated with customer complaints.
•Lead & implement Continuous Improvement projects with cross-functional teams with a view of reducing waste, including but not limited to reducing labor time and improving Yield.
•Influences and participates in the development of process technology roadmaps.
•Recommends the implementation of new technologies, processes, and equipment wherever logistically and financially justified.
•Provide training & mentorship to Engineers by sharing technical expertise and providing feedback and guidance.
EDUCATION/ EXPERIENCE AND QUALIFICATIONS:
•10+ years working experience in manufacturing & process development.
•Bachelor’s Degree in Engineering, or another technical related field is preferred.
•Strong analytical skills, solutions-and process orientated, organized and structured.
•Continuous improvement focused, self -directed and result orientated.
•Proficient in Failure & Root Cause analysis and corrective action deployment.
•Strong skills in applying fundamental engineering and scientific principles when resolving technical matters.
•Knowledge of Lean manufacturing and 6 sigma is preferred
•Excellent communication, project management, interpersonal and presentation skills.
•Medical device standard and regulation, ISO 13485, FDA 21CFR and cGMP, preferred.