Process Development Engineer IV (Staff) San Diego, CA

Process Development Engineer IV (Staff)

San Diego, California, United States

Process Development Engineer IV (Staff)

Qualifications

BS Degree in Mechanical Engineering, Bioengineering, Chemical Engineering, Manufacturing Engineering, or scientific discipline required

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)

Role model for what kindness looks like. 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

Company: ESR Healthcare