The Manufacturing Engineer will be responsible for overseeing the planning, development, implementation and maintenance of manufacturing methods, processes, tools and operations for new and existing products, including process validation within FDA and ISO guidelines. Ensures the effective use of materials, equipment, and personnel in producing quality products at minimum costs. Perform duties within established environmental, health, and safety requirements.
Work with management, production personnel, and cross-functional teams to ensure design for manufacturability; identifying equipment and processes required to manufacture new and existing products.
Responsible for project management, developing timelines, writing protocols and overseeing the performance of validations (IQ, OQ, PQ) to qualify processes and equipment in a FDA/ISO-regulated environment.
Confers with vendors to determine product specifications and arrange for purchase of equipment, materials or parts, and evaluates products according to specifications and quality standards. Knowledge of CAD software required.
Confers with establishment personnel to implement operating procedures and resolve system malfunctions.
Develops models of alternate processing methods to test feasibility of new applications of components, and recommends implementation of improved procedures.
Tests ability of machines to perform tasks.
Analyzes work study data and equipment specifications to establish time and production standards.
Interfaces with manufacturing departments to address and resolve engineering issues.
Work with management and production to drive cost reductions, yield improvements, and efficiency improvements towards World Class Manufacturing goals.
Properly document activities in accordance with best engineering practices, company procedures and regulatory requirements.
Follow good project management practices.
Bachelor's Degree in Engineering (Mechanical, Electrical, Biomedical)
At least 1 year of experience working in an Engineering capacity in a medical device, pharmaceutical or aerospace regulated manufacturing environment.
Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.