Job Information
Actalent Sr. Manufacturing Process Engineer in Fremont, California
Description:
The Manufacturing Engineer III supports new product Introduction and existing products improving productivity, efficiency and yield. Leads assembly line and equipment qualifications and manufacturing process changes. Develop master validation plans and appropriate protocols and report. Creates and maintains documentation to comply with FDA and ISO regulations. Provide technical support to existing products and processes using structured methods based on Lean Manufacturing and Six Sigma methodologies.
Key Responsibilities:
Creates and maintain proper manufacturing documentation as SOP’s, Operator and process instructions, forms and reports.
Assembly line incorporation based on lean manufacturing principles
Assures ISO and FDA regulation compliance
Responds to CARS, NCR, and SCRs with definitive solutions that eliminate recurrence and promote process improvement.
Interacts with customer to answer corrective actions, engineering changes and supplier change requests.
Develops and execute cost reduction and continuous improvement projects applying Lean manufacturing and Six Sigma principles.
Designs and implements fixtures and jigs to improve manufacturing operations (assembly, inspection, visual aids, etc)
Identifies, structures and executes continuous improvement activities (Opex events), cost reduction initiatives and efficiency improvement projects.
Determine root cause analysis, and implement corrective and preventive action plans.
Develop, write, and execute Validation Protocols (IQ/OQ/PQ), reports, internal audits, work instructions.Analyses Data (SPC, DOE,) to find causes of variation and address proper correction or improvement.
Monitors KPI’s and overall performance of assembly lines and secondary operations to identify improvement opportunities.
Reviews, maintain BOMs and routings up to date in accordance with improvements and modifications to new or existing processes.
Qualifications
Bachelor’s degree in Engineering (Industrial, Manufacturing, Electro-Mechanical or equivalent) OR relevant work experience
Hands on experience
Experienced in MS office tools (Word, Excel, Powerpoint, Project etc.)
Experience with CAD Software (Solid Works & AutoCAD) preferred.
Experience with Data Analysis software (Minitab)
Lean manufacturing and Six Sigma black belt certification or higher required
Requirements, Skills & Experience
8 - 10 years experience in the position
Work and Time studies
FDA and ISO regulated environment.
Secondary Operations qualification
Assembly line development. Line balancing, One piece flow and JIT focus
MRP experience IQMS or similar
BOMs and routing creation and modification
Self-motivated, requiring minimum supervision
Software familiar: Microsoft office, Minitab, Project, Autocad
Skills:
injection molding, troubleshooting, design for manufacturing, process development, manufacturing engineering, documentation, Analytical Problem Solving, IQ, OQ, PQ, process improvement, manufacturing process, Solidworks
Experience Level:
Intermediate -> Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.