Icon hamburger
US
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now
Thumsup

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Id650l6fnsvccfbcgfz

Sr. Engineer

Ultimate Irvine Seasonal/Temp
$45.00 - $50.00 / hour
Apply Now
A global Medical Device Company in Irvine, CA is looking to identify and hire a Senior Supplier Development Engineer, who will provide manufacturing engineering support in the design and development of novel Transcatheter Mitral and Tricuspid therapy devices (TMTT). This individual will conduct operations engineering activities at key suppliers from initial product development phase through commercial product launch. Among these activities are: applying Design for Manufacturability (DFM) concepts into component designs, collaborating with suppliers in the development of highly capable manufacturing processes to meet new product demands, performing process failure mode analysis, conducting supplier process validations and others related to design-transfer-to-manufacturing at suppliers. This is a dynamic, hands-on and supplier-focused role that will work in close partnership with R&D, Supplier Quality, Global Sourcing and Manufacturing Plants.

Key Responsibilities:
  • Working with multiple internal project teams to coordinate and execute supplier development deliverables at external plastic, metal, and sub-assembly component suppliers for company TMTT products.
  • Assisting suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet company procedures, ISO 13485 and FDA requirements.
  • Being the primary contact for designated suppliers and ensuring that all phases of product/process development conform to required quality standards while meeting program timing/key milestones for production launch.
  • Developing and writing technical reports/summaries, and validation/verification documents. Properly documenting activities in accordance with best engineering practices, company procedures, and regulatory requirements.
  • Resolving supplier component-related problems, including yield issues and failure analyses.
  • Providing ongoing quality monitoring and interface with external suppliers on manufacturing line issues to ensure highest quality product is maintained.
  • Training and educating suppliers on industry best practices and requirements to develop and improve their ability to meet medical device manufacturing industry expectations.
  • Facilitating and managing component level qualification testing that leads to the approval of components for use in TMTT products.
  • Conducting supplier assessments to drive selection of robust suppliers and development plans for those suppliers needing performance improvement.
  • Supporting the generation and implementation of the Supplier Development department's quality system procedures such as initiation of SQRs, purchased part DMRs, FAI reports
  • Perform other duties and responsibilities as assigned.
Skills & Qualifications:
  • Bachelor's degree in an engineering or scientific field is required.
  • 4+ years of engineering experience in medical device manufacturing 
  • Well-developed understanding and with experience in performing medical device manufacturing process validations (IQ/OQ/PQ).
  • Equipment knowledge and process experience for injection molding, catheter manufacturing, high volume product assembly, and environmental controls (clean rooms and water processing) preferred
  • Good engineering judgement and demonstrated analytical, quality problem analysis, and resolution skills using Six Sigma methodologies.
  • Strategic planning and critical thinking skills to be able to plan, organize, and manage multiple priorities.
  • Ability to read and interpret engineering drawings for the purpose of understanding product design and identifying to critical to quality features.
  • Strong understanding of statistical techniques (Gage R&R, SPC, Process Capability Analysis, ANOVA, etc.) is required. Lean Six Sigma certification is preferred.
  • Ability to work well both independently and as a member of a team is essential.
  • Excellent documentation and communication skills and interpersonal/intercultural relationship skills including negotiating and relationship management skills.
  • Knowledgeable in the use of Software: MS Office Package, Minitab (or equivalent statistical analysis software)
  • Ability to travel both domestic and international is required. Expected 25%-30% travel


We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
 

Recommended skills

System Procedures
Performance Improvement
Testing
Statistics
Validations
Documentation
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

Job ID: JO-1909-69852

CAREERBUILDER TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.


We never wanted to be the biggest...only the best. By treating our Ambassadors with the respect and dignity they deserve, tens of thousands of professionals across the country have become loyal fans of who we are.

View the full profile