Directs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering activities within area of assigned responsibility.
Main Job Responsibilities:
Follow and develop quality and regulatory requirements including company policies, procedures, and appropriate regulatory requirements.
Plan, develop, and execute process and test method validations (IQ, OQ, PQ) in accordance with company procedures and guidelines.
Communicate ideas, information, and recommendations clearly, effectively, and frequently (oral and written) within the company, with outside suppliers or partners, and with customers during formal and informal interactions.
Prepare or review documentation with a high degree of accuracy, completeness, and effectiveness using common engineering tools and templates where available (e.g., specifications, manufacturing procedures, DCOs, and technical reports or analysis).
Apply and promote lean manufacturing techniques to continuously improve cycle times and process flows. Identify, support, or direct the execution of improvement efforts to reduce waste in all manufacturing and business processes.
Use structured problem-solving techniques and statistical methods for data-driven analysis and decisions.
Apply and lead DMAIC-Six Sigma approaches to solve issues and reduce variation in all manufacturing and business processes.
Plan, execute, and manage project activities with cross-functional teams. Project types can include new product development and introduction, manufacturing transfers, continuous improvement, and cost reduction initiatives.
Follow and adhere to standard work.
Support and participate in the lean manufacturing cultural change to drive out waste in manufacturing processes.
Support and participate in continuous improvement activities.
Support and participate in activities that increase the ratio of value-added to non-value-added processes.
Demonstrate leadership through mentoring of junior staff, responsiveness to business needs, and motivation of diverse, cross-functional teams, including influencing both internal and external members to achieve positive business results.
Demonstrate technical ability through the application of engineering skills, approaches, and knowledge.
Take financial responsibility for activities to create positive impact to the business.
Perform all duties and direct others, creating a safe working environment for our employees and our communities.
Perform other duties as necessary.
Position Requirements:
Knowledge/Education:
Bachelor of Science in Engineering/technical field and minimum of 5-7 years of experience (1+ years in the medical device industry).
Postgraduate studies will be taken into account.
Lean manufacturing and new product development or launch support experience is highly desirable.