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Supplier Development Engineer
Full-Time
  

 

POSITION SUMMARY:
Supplier Development Engineer is responsible for selection and development of assigned products/suppliers for production, new product development, and non production materials on a company wide basis.

 

DUTIES & RESPONSIBILITIES:
Reporting to the Supplier Development Manager, key responsibilities of this position include:
  • Company wide leadership for supplier development coordination with external battery supplier, capacitor supplier and other mechanical implantable components.
  • Provide technical expertise and leadership to sourcing and development of suppliers with respect to technology, performance, quality, cost, logistics, and delivery.
  • Assist suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet state of the art ISO and FDA requirements.
  • Ensure suppliers are able to meet requirements for performance, quality, cost and delivery of components and company requirements for supplier certification. 
  • Conduct supplier audits, supplier ratings and risk assessments, and cost reduction programs, resolve supplier quality issues and driving continuous improvements for components.
  • Facilitate and manage qualification testing that leads to the approval of components for use in implantable products.
  • Monitor and track the progress of supplier’s development, internal conformance to standards and readiness evaluations
  • Provide ongoing quality monitoring and interface with external vendors on line issues to ensure highest quality product is maintained.
  • Provide ongoing quality monitoring and interface with external vendors to ensure highest quality product is maintained. 
  • Resolve supplier component-related problems, including yield issues and failure analyses.
  • Evaluate and recommend corrective actions to improve process yields.
  •  Provide guidance and direction with corrective actions for designated suppliers.
  • Lead the effort to develop new process technology to support the manufacturing and ramp of next generation device projects
  • Perform as the primary contact for designated suppliers and ensure that all phases of product development meet program timing and conform to required quality standards.
  • Assist with new product development by working with suppliers to ensure that key milestones are achieved and products are ready for production launch.
  • Train and educate suppliers on industry best practices and requirements to develop and improve their ability to meet world class expectations.
  • Conduct and train suppliers in process design, experiment, evaluations, and data analysis.
  • Work with internal groups such as Program Management, Design Engineering and Quality Engineering to resolve component part issues.
  • Support management with all supplier development strategies and initiatives. Provide input and direction on all initiatives in order to constantly improve the overall effectiveness of Supplier Development 
  • Interface with Design Engineers to provide timely feedback on proposed designs and influence organization to develop strong design for manufacturability culture. 
  • Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.

 

POSITION QUALIFICATION REQUIREMENTS:
  • Bachelor of science degree in Materials Science, Mechanical Engineering, and 3 years of experience in medical or other high-reliability manufacturing environment, or equivalent combination of education and experience.
  • Demonstrated strategic planning and critical thinking skills to be able to plan, organize and manage multiple complex priorities.
  • A well developed understanding of manufacturing process validation methodology to meet ISO and FDA requirements.
  • Experience with Just in Time and Lean Manufacturing techniques.
  • Demonstrated analytical, quality problem analysis and resolution skills using Design of Experiments and Statistical Process Control.
  • Ability to read and interpret engineering drawings for the purpose of understanding equipment function and product design.
  • Strong written, presentation and communications skills.
  • Proven ability to multi-task and meet deadlines in a dynamic environment
  • Proven strong interpersonal, management and supervision skills
  • Demonstrated negotiating skills
  • Excellent computer knowledge and skills.

 
POSITION PREFERENCES:
  • Medical Device manufacturing experience, including ISO and FDA requirements.
  • Equipment knowledge and process experience for glass to metal seals, spot welding, adhesive bonding, or laser welding.
  • CAD Mechanical design experience developing tooling and fixtures.


Contact Information
opportunities@cameronhealth.com