Manufacturing Engineer IV (Staff) San Diego, CA

ESRhealthcare
San Diego, CA
Category Engineering
Job Description
Manufacturing Engineer IV (Staff) for San Diego Manufacturing Operations, requiring 8-12 years of experience, expertise in process interactions, scaling manufacturing processes, and quality and regulatory standards.

Requirements

  • BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline
  • Minimum 8-12 years related experience, including years of higher-level education (MS, PhD)
  • Experience in design of experiments and statistical tools (ANOVA, t-test, etc.)
  • Experience with Fishbone, A3, 5Y, and other root cause investigation tools
  • Strong understanding of process interactions (inputs, outputs) that are both technical and system related
  • Expertise with scaling manufacturing processes to commercial volumes
  • Experience with budgeting, cost management, modeling, and preparing business proposals (ROI, NPV) for new initiatives seeking executive approval
  • Strong understanding of FDA 21 CFR Part 820 and ISO 13485 quality and regulatory standards
  • Experience with lean manufacturing and six sigma methodologies (preferred)
  • Experience with design for manufacturability concepts and product development lifecycle (preferred)
  • Experience with standard electrical, mechanical, and wet lab test equipment (preferred)
  • Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationships
  • Proficiency in Microsoft Office tools
  • Proficiency with JMP, Minitab, or equivalent statistical software
  • Experience with ERP, MES, and other manufacturing systems
  • Proficiency in BMRAM or equivalent asset management system
  • Expertise in several specialty skillset, including injection molding, welding, analytical chemistry, microscopy, metrology, adhesives, or electronics packaging
  • Proficiency in Solidworks or equivalent CAD software (preferred)
  • Experience with MS Project, Visio, and other project management tools (preferred)
  • Experience with manufacturing database, controls, and vision (preferred)
  • Experience with Altium or other electronics design software (preferred)
  • Actively levels up those on the team through example setting, guidance, and support
  • Empowers others to make effective decisions
  • Excels at identifying solutions to accelerate teams learning of the problem space
  • Strong organizational planning and ability to hold others accountable
  • Breaks down silos within and across teams to ensure forward progress and collective success
  • Ability to take decisive action and deliver tangible results in a cross-functional organization
  • Leadership aptitude of teams, projects, and programs

Benefits

  • Competitive salary
  • Benefits package
  • Opportunities for professional growth and development
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