Process Development Engineer IV (Staff) San Diego, CA

ESRhealthcare and EXEC STAFF RECRUITERS • San Diego, CA

1d • Onsite

About The Position

Process Development Engineer IV (Staff) San Diego, CA 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 Working Place: San Diego, California, United States Company : ESR Healthcare

Requirements

• 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
• 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
• Strong leadership skills, including the ability to set goals, allocate resources to appropriate priorities, and provide constructive feedback to foster positive relationships
• Strong organizational planning and ability to hold others accountable
• Ability to take decisive action and deliver tangible results in a cross-functional organization
• Leadership aptitude of teams, projects, and programs
• Breaks down silos within and across teams to ensure forward progress and collective success
• Excels at identifying solutions to accelerate teams learning of the problem space
• 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

Nice To Haves

• 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)
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level