Ecocareers · 3 months ago
Process Development Engineer
Irvine, CA
Full-time
Onsite
Mid LevelConfidential company is seeking a Process Development Engineer to oversee the execution of process development and validation projects. The role involves creating test reports, writing process instructions, and collaborating with cross-functional teams to ensure project deliverables are met in accordance with company policies.
Staffing & Recruiting
Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are
Must be able to perform characterization studies with statistical analysis and create test reports Process Development and Validation Experience is a must
Must write process instructions, manufacturing operating procedures, and PFMEAs Must build equipment and setup manufacturing line(s)
Process and run engineering Wos
Able to travel within USA and Mexico if required to write and execute IQOQPQ
Must be able to write and stage CRs CNs in Windchill Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc
Actively coordinate and mitigate delays within project and tasks Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
Release Comments: EIS : Medical Device & Regulations EIS : New Product Development (NPD) Methodology and Management
Qualification
Required
Must be able to perform characterization studies with statistical analysis and create test reports
Process Development and Validation Experience is a must
Must write process instructions, manufacturing operating procedures, and PFMEAs
Must build equipment and setup manufacturing line(s)
Process and run engineering Wos
Able to travel within USA and Mexico if required to write and execute IQOQPQ
Must be able to write and stage CRs CNs in Windchill
Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments
Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC
Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions
Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders
Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc
Actively coordinate and mitigate delays within project and tasks
Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
EIS : Medical Device & Regulations
EIS : New Product Development (NPD) Methodology and Management
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase