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Staff Supplier Development Engineer

Compunnel Inc. Irvine, CA
  • Expired: 26 days ago. Applications are no longer accepted.

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 Edwards TMTT products.
  • Assisting suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet Edwards’ 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 SQR, purchased part DMRs and FAI reports
  • Perform other duties and responsibilities as assigned.

Required Education & Skills

  • The ideal candidate requires a Bachelor's degree in engineering; mechanical or biomedical is preferred and a minimum 6 years of experience in the medical device industry OR a Master's degree in engineering or materials in combination with 5 years of medical device experience.
  • 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

Compunnel Inc.

Why Work Here?

Room for growth and weekly pay and you get to work with a team of the best 'hand picked' people in the world.

Compunnel Inc. has always been and will always be an Equal Opportunity Employer. Where every individual, solely on their merit, qualification and competency not only has equal economic opportunity but also for recruiting, training and career development. Our 2000+ members reflect a culture of diversity and inclusion and bring their authentic, original and best selves to work. Our inhouse team who looks over no discriminate against any employee and puts affirmative actions has full support of our Chief executive officer Andy Gaur and its top leaders branched out across Compunnel.

Address

Irvine, CA
92614 USA