Medical industry manufacturing engineer

Descripción general

Responsibilities

• Lead a dedicated group of engineers and technicians within the Project or Manufacturing Group.
• Make sure engineers are fully integrated into the overall project and production support team.
• Plan and implement training and development plans with subordinates.
• Complete design and development projects by training and mentoring technicians.
• Establish engineering goals and objectives that deliver results in accordance with the business plan. Identify and establish permanent and effective technical / systems solutions to problems.
• Consistently meeting customer requirements and commitment to performance excellence and meeting deadlines.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Identify and develop improvements to increase the key metrics of the Service, Delivery, Quality and Cost process using Lean / 6 sigma methodologies.
• Lead or guide projects in conjunction with other resource management (ie, NPI, quality engineering, design assurance, R&D, and other cross-functional departments) related to engineering. Work with the team to plan, coordinate and implement activities to support the successful launch of new products, including purchase / purchase analysis, introduction of new processes and others. Develop / modify manufacturing processes by studying product requirements; research, design, modify and test manufacturing methods and equipment.
• Supervise and drive validation activities, including equipment IQ / OQ, process OQ / PQ, process characterization, attribute / variable test method validation and associated documentation.
• In-depth knowledge related to the links between the Validation Master Plan, pFMEA, dFMEA

Requisitos para aplicar

Education and Experience

• Bachelor's degree in an Engineering field or equivalent, with 5-10 years of experience in a demanding high-volume production environment.
• Knowledge of medical devices or similar quality and manufacturing systems is essential.
• Experienced user of CAD tools, preferred SOLIDWORKS experience.
• A demonstrated ability to lead a focused production / technical problem solving team with a proven track record of line setup including equipment acquisition and process development
• Working knowledge of sigma and / or lean engineering principles with a proven track record in use and delivery of results.
• Statistical knowledge, including data analysis and the use of statistical software (JMP, Minitab, etc.).
• Lean Six Sigma - Green Belt certification preferred
• Excellent communication, planning and organization skills.
• Willing to carry out an assignment abroad of up to 3 months and work on their own initiative during the assignment.
• Must be fluent in English, both written and verbal, more than 80%