MANUFACTURING ENGINEER I
Job Overview
What your background should look like:
Key Responsibilities
Learn, apply, and share knowledge of products, manufacturing processes, and equipment.
Lead or participate in productivity improvement projects.
Lead or participate in cost-reduction initiatives (e.g., scrap reduction, inventory and cycle time reduction, flow improvement).
Monitor manufacturing processes, measure key characteristics, and analyze variation to reduce waste.
Analyze data and provide input for decision-making related to key process indicators.
Lead or support the introduction of new part numbers into existing technologies.
Lead validations for processes and equipment (IQ, OQ, PQ).
Source and implement new technologies that improve operations (e.g., increased capacity, obsolescence, ergonomics)
Collaborate with cross-functional teams to resolve product quality issues (e.g., NCMRs, CARs, SCARs, CAPAs).
Execute all additional tasks related to the manufacturing process.
Competencies & Skills
Ethics and Values: Commitment to quality and effectiveness.
Project Completion: Timely execution of improvement projects.
CAPA/NCMR Closure: On-time resolution of corrective actions.
Adaptability: Flexibility to work under pressure and adapt to change.
Continuous Improvement: Active pursuit of process enhancement.
Validation Compliance: Adherence to validation protocols and standards.
Education Requirements
Bachelor’s degree in Industrial, Mechanical, Electromechanical Engineering, or a related field.
Experience Requirements
Desirable: 2 years of experience in process development, equipment validation, or production support in the medical device industry.
Preferred knowledge of:
FDA and/or ISO 13485 standards.
SolidWorks, Minitab, Excel, Power BI.
Lean Manufacturing, Six Sigma, and Quality Systems.
English proficiency required.
Competencies
San Jose, A, CR, 20108
Job Segment:
Manufacturing Engineer, Lean Six Sigma, Medical Device Engineer, Six Sigma, R&D Engineer, Engineering, Management