Manufacturing Process Improvement Specialist
hace 2 semanas
Main Job Responsibilities
As a Manufacturing Process Improvement Specialist at Viant Medical, you will be responsible for analyzing current manufacturing methods and practices, recommending, developing, and prototyping new processes and production methods to enhance manufacturing efficiency.
Main Job Duties and Responsibilities
- Follow all personal and manufacturing Good Manufacturing Practices (GMP's) as defined by Vention's practices, policies, and Standard Operating Procedures (SOP's) to ensure that FDA regulations are met.
- 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 specifications 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 trouble-shoot 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. Confirm conformance to engineering designs and methodologies and verify overall safety. Prepare reports on these activities.
- Negotiate and place orders with Vention vendors. Maintain vendor relations; problem-solve with vendors; may recommend termination of vendor relations.
- Attend conferences, take coursework, and continuing education programs to maintain or improve knowledge and practices relevant to medical device manufacturing.
- Provide drafting or design drawings to support manufacturing processes recommendations.
- Perform other duties as assigned.
Requirements
Knowledge / Education
- Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or science-related engineering discipline or within 1 year of completing one of the above degrees (Senior Student).
- Knowledge on ISO 14971 and Knowledge on CRF 820 CGMPs is a plus.
Work Experience
- From 0 to two years of experience in a manufacturing environment. Experience within the medical manufacturing field is a plus.
Skills / Competencies
- Proficient in Microsoft Office software and possess a general working knowledge of Auto Cad, Pro Engineer, or similar engineering program.
- 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.
- Excellent written and oral English skills.
Equal Employment Opportunity
Viant provides equal employment opportunities (EEO) 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. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
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