Manufacturing Process Improvement Specialist
hace 7 días
**Job Title**: Manufacturing Process Improvement Specialist
**Department**: Engineering
**Job Summary**: We are seeking a highly motivated and detail-oriented Manufacturing Process Improvement Specialist to join our team at Viant Medical. As a key member of our engineering department, you will be responsible for analyzing current manufacturing methods and practices, recommending, developing, and prototyping new processes and production methods to enhance manufacturing efficiency and productivity.
**Key Responsibilities**:
- Follow all personal and manufacturing Good Manufacturing Practices (GMP's) as defined by Viant's practices, policies, and Standard Operating Procedures (SOP's) to ensure compliance with FDA regulations.
- Perform project management responsibilities for assigned manufacturing changes or new product launches.
- Monitor and improve recommendations of fixtures, tools, and methods to meet productivity and quality standards.
- Recommend new tools and methodologies, including costing and cost estimates for design or product process changes.
- Plan, design, and develop new methods to support manufacturing processes.
- Develop or revise technical documentation to specify manufacturing processes, including documentation of equipment qualification, setup, and maintenance procedures.
- Repair and troubleshoot machinery used in the manufacturing process.
- Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes.
- Negotiate and place orders with Vient vendors, maintain vendor relations, and problem-solve with vendors.
- Attend conferences, take coursework, and continuing education programs to maintain or improve knowledge and practices relevant to medical device manufacturing.
**Requirements**:
- Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a science-related engineering discipline, or within 1 year of completing one of the above degrees (Senior Student).
- Knowledge of ISO 14971 & 13485, and CRF 820 CGMP's is a plus.
- From 0 to two years of experience in a manufacturing environment, with experience in the medical manufacturing field being a plus.
**Skills and Competencies**:
- Proficient in Microsoft Office software and possess a general working knowledge of Auto Cad, Pro Engineer, or similar engineering programs.
- Good knowledge of statistical tools.
- Ability to manage multiple tasks.
- Must be flexible and adapt to changing environments and priorities.
- Excellent communication and interpersonal skills.
Viant Medical provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.
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