**Duties and Responsibilities**:- Coordinates and directs the development of cost / quality improvement efforts for in-house production.- Creates, maintains, and improves manufacturing process and assembly documentation procedures for employee training, maintaining consistent production and quality performance, and meeting quality system requirements.- Coordinates, directs, and project-manages the design, specification development, cost justification, and vendor selection for equipment purchases, off the shelf, semi-automated, and fully automated.- Designs jigs and fixtures to support the assembly cells, sterilization, QA, and final product packaging operations.- Plans, coordinates, and directs the development of new production capacity initiatives to support the company's business / sales plan. Includes planning and maximizing production area and cell layouts.- Plans, coordinates, and directs the company's preventive and predictive maintenance program including the analysis, tracking, and recommendations for equipment / facility repair and maintenance projects.- Plans and coordinates change requests through engineering change orders.- Provides work assignment direction and oversight for equipment / facility maintenance staff.- Assists, reviews, and approves calibration and maintenance records.- Coordinates and supports QA in implementing relevant area compliance with regards to quality (ISO13485), safety, environmental (ISO 14644), and Riverpoint Medical standard procedures.- Assists and supports in performing supplier audits and supplier improvement initiatives.- Assists in process investigations of complaints, root cause assessments, nonconformity (NCR), and corrective and preventive action (CAPA) activities.**Qualifications**:- Bachelor's degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering or other related field of study or equivalent work experience- Minimum 3 years of experience providing direct daily production support in a high-mix, high and low volume, ISO regulated production environment. Production support experience supporting a FDA regulated environment is highly desirable, along with an understanding of cGMP, QSR, and ISO 13485.- Experience with LEAN initiatives and Automation- Demonstrated computer skills. Preferably in Solidworks, Microsoft Word and Excel at an intermediate to advanced proficiency level. Ability to write Excel VBA macros and / or Microsoft Access or other database software programming skills are desirable.- Demonstrated technical writing skills.Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
