**Main Purpose of Job**: (Brief Summary)
- Under the direction of the Director of Mfg Engineering or VST Manager or Designee, is responsible for the design, implementation, fixturing and methodology to support manufacturing production and efficiencies. Analyze current manufacturing methods and practices, recommend, develop and prototype new processes and production methods to enhanced manufacturing
Main Job Duties/Responsibilities (List most important first)
- Follow all personal and manufacturing Good Manufacturing Practices (GMP's) as defined my Vention's practices, policies and Standard Operating Procedures (SOP's) to insure that FDA regulations are met.
- Perform project management responsibilities for assigned manufacturing changes or new product launch.
- 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 procedure.
- 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 solves with vendors; may recommend termination of vendor relations.
- Attend conferences, take course work 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
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 & 13485. Knowledge on CRF 820 CGMP´s is a Plus
Work Experience
- From 0 to two years experience in 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
Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.