-
Process Developer
1 week ago
Titan Industries La Habra Heights, United StatesAbout the Company · Our company is a family-owned, internationally operating company in the metal processing industry. What do we stand for? - Diversity and a family-like atmosphere. With the continuous dedication of our approximately 3500 employees, the family business generates ...
-
Stellar Innovations North Garden, United StatesJOB DESCRIPTION · WELCOME TO BAUHAUS · At BAUHAUS, we rely on one thing above all else: the commitment of all employees - for each other and for every single customer. Because only with respect, teamwork, and passion is it fun to give our all every day. We look forward to working ...
-
Senior Engineer, Process Development
2 days ago
AbbVie Irvine, United StatesJob Description · This position is an individual contributor function, working with a team of scientists, engineers and laboratory support personnel to provide technical support to the Neurotoxin & Biologics Process Science (NBPS) at AbbVie. The NBPS supports the R&D Biologics pi ...
-
Senior Engineer, Process Development
1 week ago
AbbVie Irvine, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic area ...
-
Orthofix Irvine, United StatesWhy Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, w ...
-
Senior Engineer, Process Development
6 days ago
AbbVie Irvine, United StatesJob Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...
-
Spectrum Innovations Rancho Santa Margarita, United StatesAbout Kesseböhmer Group: · Our company is a family-owned, internationally operating company in the metal processing industry. What do we stand for? - Diversity and a family-like atmosphere. With the continuous dedication of our approximately 3500 employees, the family business ge ...
-
Manager - Operations - Hospital Volunteers
1 week ago
Kaiser Permanente Irvine, United States**Job Summary**: · **Essential Responsibilities**: · - Provides developmental opportunities for others; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; works closely with employees to set goals and provide open feedback and coachin ...
-
RPADeveloper (Uipath)
1 week ago
Q1 Technologies Irvine, United StatesRPA UI Path · Irvine, CA (Onsite) · Full Time Employment · - Automation Design and Development: Collaborate with business stakeholders to identify and document automation requirements. Design, develop, and maintain RPA workflows using UiPath Studio to automate manual and repetiti ...
-
Director, Engineering
1 week ago
Edwards Lifesciences Irvine, United StatesMake a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients' lives. As part of our sewing, assembly, delivery, and distribution teams, y ...
-
Scientist I, Biomaterials
3 days ago
AbbVie Irvine, United States**Company Description** · **Job Description** Key Responsibilities** · - Responsible for formulation development of next-generation facial filler through synthesis, processing, & characterization of biomaterials. · - Utilize experience involving medical device & combination produ ...
-
Compensation Specialist Ii
1 week ago
Alliant Insurance Services Irvine, United StatesAt Alliant Insurance Services, we thrive on creating employee benefits solutions built on the idea that health makes growth possible. As top tier professionals dedicated to solving our clients' health and welfare insurance challenges, Alliant team members deliver an unrivaled dep ...
-
Talent Development Manager
1 week ago
Supernal Irvine, United StatesSupernal is at the forefront of creating emerging mobility solutions that will foster the development of human-centered cities. We are designing a completely new electric vertical take-off and landing (eVTOL) aircraft tailored to the mobility needs of future cities. This allows p ...
-
Manager, Quality Training
1 day ago
Edwards Lifesciences Irvine, United StatesImagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for pro ...
-
Financial Analyst
1 week ago
Profit by RPO Irvine, United States**Job title: 25280 Financial Analyst II** · **Job location: Irvine, CA 92612** · **PRIMARY OBJECTIVE**: · The Finance System Analysts primary responsibilities will be to develop and improve the Global Financial Planning tool with the supervision of the Finance Systems Director. · ...
-
Nikkiso Cryogenic Industries Irvine, United States**Financial Process, Policy, and Procedures Specialist** · **Company Summary** · Nikkiso Clean Energy & Industrial Gases is a leading provider of cryogenic pumps, heat exchangers, process systems, turboexpanders, services, and solutions for the liquefied natural gas (LNG), liquef ...
-
Lead Project Manager, Supplier Quality and
6 days ago
Rivian Irvine, United StatesAbout Rivian: · Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. · As a company, we constantly challenge what's possible, never simply accepti ...
-
Sales Assistant
3 days ago
Hyundai Transys Georgia Seating System, LLC Irvine, United States**Job Overview**: · Lead Customer interface for the advanced sales function. Lead to solve the commercial issues and to enhance customer relationships to ensure sustainable business with the current customer(s) and to make new business with our potential customers. · **Responsibi ...
-
Mgr, Medical Dental Integration
1 week ago
Pacific Dental Services Irvine, United States: · Overview: · The Program Manager, Medical Dental Integration (MDI) is responsible for the strategy, execution and outcomes of PDS medical and dental integrated partnerships. The incumbent is the primary point of contact for PDS and all external partners as it relates to integr ...
-
Package Design
1 day ago
Broadcom Irvine, United StatesPlease Note: · **Job Description**: · Work with Business Units chip design team & Analog / Digital IP / Phy owners (e.g. 224G PAM4, 112G PAM4, HBM3/4) for new advanced node silicon (5nm, 3nm, 2nm..) chip floor plan & IP bump pattern design and optimization for package design requ ...
Principal Engineer, DS Manufacturing Process Development - Irvine, United States - JenaValve Technology, Inc.
Description
Job DetailsJob Location :
Irvine, CA
Position Type :
Full Time
Education Level :
4 Year Degree
Salary Range :
$150, $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.
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.
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.
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 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
Principal Engineer, DS Manufacturing Process Development professionals in Irvine
-
Josh Miller
Executive Level Leader and Industrial Engineer
-
John Kemp
Director Technology