HireDiversity

Neuchâtel, CH

Senior Process Engineer-000007Q4

Description
- Critically assess and improve medical manufacturing processes and equipment to achieve cost reductions and quality improvements
- Manage reliability improvement, cost improvement, new product introduction, technology or automation projects in the plant
- Provide engineering input to solve complex manufacturing process problems in the medical assembly environment, including a continuous focus on plant equipment and manufacturing processes
- Provide technical inputs to plan, design, develop and validate manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Procurement, Supply Chain, Manufacturing, Regulatory and Environmental/Safety
- Utilize Process Excellence methodologies to improve manufacturing processes
- Lead or serve on a project team to specify, select, install, and validate new automated medical manufacturing assembly equipment
- Provide detailed financial evaluations of manufacturing processes, including analyses of capital purchases, assessments of vendor costs, calculations of product standard costs, and analysis of cost-savings initiatives to satisfy company financial commitments
- Review and or create user requirement specifications for new equipment/processes to adequately address stakeholder requirements
- Manage the technical interface with key vendors through the process of design, procurement, design reviews, and installation. Complete equipment factory acceptance tests (FATs) at vendor locations
- Coordinate equipment installation and validation activities and requirements with all functional site departments
- Create and execute validation strategies for medical device assembly processes, including writing validation protocols and reports, executing process tests, and analyzing the resulting data from validation activities
- Collect data to justify project spending, present results to project stakeholders, and provide periodic project updates
- Use expertise to design/troubleshoot/optimize manufacturing solutions
- Ensure all Health, Safety and Environment requirements are met and new standards are implemented
- Maintain project documentation and files and, where appropriate, suggest improvements to systems and procedures

Qualifications

- Engineering degree from an accredited technical or manufacturing engineering program is required
- Experience required in manufacturing, process, and equipment engineering with 5-10 years of experience. Previous work experience in the medical device or pharmaceutical industry is desirable
- Experience leading a cross functional project team and demonstrated project management skills to achieve quality improvements and cost reductions is required.
- Demonstrated experience in development of manufacturing processes, preferably automated processes, is required.
- Experience in equipment, process, and computer system validation (CSV) requirements and execution
- Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, sampling statistics and techniques, CTQ flow down, pFMEA, fish bone diagrams, etc. Process Excellence Six Sigma or Lean certification is highly desirable
- Demonstrated vendor management experience is required to communicate user requirements for new equipment, monitor equipment build status, and test equipment against user requirements.
- Demonstrated experience in the development and execution of project budgets and plans
- Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation.
- Strong time, budget, and program management skills
- Able to travel up to 25%

Primary Location:Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel
Organization: Ethicon SarL (8786)
Job Function: Engineering (Generalist)