Operational Excellence Engineer

MAIN PURPOSE OF JOB

Responsible for supporting key deliverables, tied to continuous improvement efforts. These efforts include management infrastructure, operating systems, mindsets/behaviors and capabilities. This individual will coach and support site staff on the use of lean methodology and application in a medical device manufacturing environment. In addition to coaching staff this individual will monitor and present key performance indicator results weekly. This position requires excellent interpersonal relationship skills, and the ability to prioritize daily objectives in a timely manner.

MAIN JOB RESPONSIBILITIES

  • Responsible for following all GMP’s and SOP’s as defined by Viant Medical’s policies, practices and procedures to ensure that the Food and Drug Administration (F.D.A.) and ISO regulations and Viant Medical’s quality standards are met.
  • Support and lead 5S activities and guide others on implementation Viant operating systems
  • Lead Kaizen events (RIEs), and collaborate with a multidisciplinary team to reduce waste and improve overall efficiency
  • Manage and lead tactical implementation plans with core team members
  • Provide technical leadership to problem solving and solution planning
  • Collaborate with team members on DMAIC and application within clean rooms
  • Work with process owners on removing barriers and sustaining process changes
  • Drive organizational alignment by applying the three critical lenses of operational excellence
  • Design future state operational improvements and calculate forecasted KPI impact
  • Able to data mine from multiple data sources and analyze data for decision making
  • Confident in the delivery of daily and weekly progress to key stakeholders
  • Support site CAPA root cause investigation, corrective actions, preventative actions, solution execution, and verification of effectiveness.
  • Apply risk reduction tools (FMEA) to operating systems and manufacturing processes
  • Apply risk reduction actions to manufacturing lines and prioritize based on impact

POSITION REQUIREMENTS

KNOWLEDGE / EDUCATION

  • BS/BA in Engineering or Technical Discipline
  • Lean Experience

JOB EXPERIENCE

  • 1-3 years of related experience in a regulated industry, FDA QSR, ISO1348 and ISO14971 Risk Assessment
  • Experience in CAPA and Operational Excellence Initiatives
  • Experience in medical device or related regulated industry
  • Additional candidates may be considered based on job experience

SKILLS / COMPETENCIES

  • Demonstrated track record of leading within complex organizations requiring strong influential communication skills
  • Experience working in problem solving, including clear understanding of the roles and responsibilities of cross-functional project teams
  • Facilitation, training and coaching experience
  • Ability to develop and provide compelling and influential arguments and data to support his/her position
  • Ability to work cooperatively at all levels in matrix environment to build and maintain positive relationships required to accomplish organizational goals
  • Excellent communication skills and interpersonal/team effectiveness- ability to succinctly and accurately communicate to various levels of employees
  • Business acumen; ability to think from an overall “best for the business” perspective
  • Demonstrates initiative; results oriented
  • Strong analytical, planning, organization and time management skills to effectively execute project plans and budgets
  • Effective decision making skills – ability to negotiate and balance decisions and priorities across needs of several business units and stakeholders
  • Makes timely decisions in the face of risk and uncertainty
  • Customer focused in all interactions, demonstrated ability to understand customer external and internal requirements and incorporate into business decisions

PHYSICAL REQUIREMENTS

  • Office position; long periods of sitting, standing, walking, and usage of computer
  • No unusual or excessive physical demands
  • 25% travel requirement

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. 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.