Job Details
Job Location :
Irvine, CA
Position Type :
Full Time
Education Level :
4 Year Degree
Salary Range :
$150,000.00 - $160,000.00 Salary/year
Description
Job Title
: Principal Engineer, DS Process Development
Principal Engineer I, DS Process Development
Principal Engineer II, DS Process Development
Principal Engineer III, DS Process Development
Supervisor/Manager Title:
Manager, DS Manufacturing
Job Description Summary:
Responsible for process development and manufacturing engineering activities. Act as an interface between R&D, pilot, and commercial manufacturing.
Contributes to the Delivery System product life cycle. Optimization and development of new or current manufacturing processes.
Job Responsibilities:
Technical engineering support for delivery systems to ensure process and equipment are characterized and scaled by utilizing new technology and standard work.
Lead/support equipment, tooling, and fixture design for development and production activities.
Identify and implement manufacturing process improvements internally and at contract manufacturers.
Analyze and resolve complex manufacturing and compliance issues (CAPA, non-conformances, audit observations, etc.).
Lead short-term and long-term manufacturing process improvement activities.
Partner with Quality and R&D Engineers to develop and implement critical manufacturing processes.
Process development of manufacturing processes and validations (IQ/OQ/PQ) for new product introduction and continuous improvement.
Provide root cause analysis investigations and development/implement corrective actions for component and device nonconformance.
Managing key suppliers and working directly with contract manufacturers.
Provide technical support for design qualifications, design transfer, activities for regulatory submissions, product and process development and implementation of design control documents, and approval of product/process change.
Manage all manufacturing-related aspects of the project within a team.
Develop training and documentation materials (e.g., work instructions) for development and production activities.
Provide real time production line support.
Qualifications
Required Education and Experience:
A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
Minimum of 12+ years' experience in Manufacturing or R&D Engineering is required with a preference in delivery systems or catheters.
Level I, II, III DOE.
Must have experience in the use of CAD (SolidWorks) packages.
Knowledge of equipment qualification (IQ/OQ/PQ) and design verification (including statistical techniques used) in the medical device industry or other regulated industries is required.
Must have experience in designing and implementing fixturing from design concept to a clinical/commercial production line.
Must have experience in implementing equipment from parameter/settings origin to the production line.
Knowledge and experience in Work Instruction creation and implementation.
Skills and Abilities Required for This Job:
Must have experience in the use of CAD (SolidWorks) packages.
Must be able to work effectively and collaborate within cross-functional teams.
Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
Must have strong project management and documentation skills.
Must take initiative and have the ability to conduct hands-on work.
Must possess the ability to handle multiple tasks with high attention to detail.
#J-18808-Ljbffr
