Danaher Corporation Process Engineer – Consumables Automation in Newark, California
The successful candidate will use their industry experience to design and develop and monitor assembly processes for medical device manufacturing.
They will evaluate current capabilities, available technology in the industry, and product requirements to develop new and improve current assembly methods and processes. Use statistical analysis to monitor assembly processes and drive continuous improvement in collaboration with a diverse and highly talented engineering team. This is a hands-on position involving process characterization, validation (transfer to production) and process monitoring, must be able to interface well with other engineers, scientists and operations personnel. Experience with automated assembly equipment and high-volume manufacturing is required.
ESSENTIAL JOB RESPONSIBILITIES:
Design and perform process characterization studies & DOE’s to develop new and/or improve existing assembly processes.
Design, test, and validate new automation processes and/or designs in collaboration with a diverse functional engineering team.
Write Verification/Validation protocols (I/OQ, PQ) and related technical reports to support the transfer of processes into Production.
Partner with cross functional teams to evaluate design and processes at concept phase and define manufacturing processes.
Develop new and/or improved processes for parts and assemblies through the application of theoretical and practical engineering.
Assist in failure investigations and root cause analyses as they relate to process performance.
Use statistical analysis, and hands-on bench or line testing to characterize attributes, process performance, and equipment assembly characteristics.
Generate documentation including Operating Procedures, Engineering Studies and reports.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree in field with 5+ years of related work experience OR
Master’s degree in field with 3+ years of related work experience OR
Doctoral degree in field with 0-2 years of related work experience.
Knowledge and skills:
Hands on experience with high volume automated manufacturing equipment.
Working knowledge of GMP, ISO, and FDA rules and regulatory requirements. Automotive, aerospace, or other regulated industry experience may be considered.
Proven experience with DOE creation, root cause analysis, process engineering, failure investigations and automated assembly equipment.
Experience in process development, acceptance testing and qualification of equipment.
Excellent communication skills. Must be proficient in document preparation and editing, including detailed test planning and report writing. Excellent verbal and written communication skills.
Proficiency with MiniTab, JMP and Microsoft Office applications.
Experience with creating BOMs, product specifications, and engineering drawings interpretation (GD&T).
BS in Mechanical, Plastics, or Manufacturing Engineering or equivalent combination of education and experience to perform at this level.
A minimum of 2+ years overall related engineering experience within medical device or a regulated industry.
Project management experience would be a plus.
Quality Management System experience preferred.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.