Supply Chain Engineering Lead

The Supply Chain Engineering Lead will work closely with manufacturing suppliers to ensure they are producing high quality and cost-effective production components. This individual will work closely with development engineers and is responsible for selecting/evaluating new suppliers, and ensuring suppliers meet requirements for product safety, quality, cost, delivery, and service.  Monitor supplier performance, and drive suppliers to continuously improve business and manufacturing processes. The Supply Chain Engineering Lead may be required to perform all or a combination of the following essential responsibilities as determined by necessity. This position will report to the VP, Operations. This role will be located in the Company’s Woburn, MA office.

Essential Responsibilities:

  • Work with R&D engineers to assess and refine designs to optimize for manufacturing and assembly
  • Collaborate with R&D and Quality engineers in supplier selection and evaluation activities, providing assessment of material selection, manufacturing capabilities, and quality controls
  • Develop plans for supplier evaluation, qualification, onboarding, and monitoring, including establishment of supplier metrics and key performance indicators (KPIs)
  • Oversee supplier process development and validation for new product introductions and sustaining engineering activities
  • Facilitate the evaluation of new and revised processes to determine the supplier’s ability to meet specifications
  • Act as liaison with suppliers and communicate product design requirements and quality issues as needed
  • Provide engineering guidance to Incoming Inspection personnel including measurement techniques and statistical analysis
  • Improve supplier manufacturing processes to help reduce incoming inspection rejections and final assembly losses
  • Initiate strategies to improve product cost and quality with suppliers and engineering team
  • Assist and participate in negotiations and the establishment of applicable supply agreements, contracts, and purchase order terms and conditions

Experience & Training:

  • A minimum of a bachelor’s degree in Engineering, Manufacturing Engineering is required
  • Minimum of 5 years of medical device product development/manufacturing, supply chain engineering experience required
  • Knowledge of electronics, plastics, and metal component manufacturing in medical device new product introductions, manufacturing transfers, and supply chain
  • Experience in sourcing materials to support product development initiatives, electronics based medical device finished products manufacturing, and assembly-oriented manufacturing environments
  • Experience with ISO 13485 compliant medical device projects and manufacturing environments
  • Working knowledge of Quality System elements including Design Controls, Design History File (DHF), Device Master Record (DMR), CAPA, SCAR, NCMR
  • Excellent interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues
  • Strong written and verbal communication and presentation skills. Ability to present and effectively communicate complex clinical and technical data to the audiences of various backgrounds and knowledge levels
  • Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities, and multiple deadlines
  • Working knowledge of statistics software packages such as Minitab, and standard Project Management tools such as MS Project/Smartsheets, Excel, Word, etc.
  • The ability to collaborate with all levels of management in a matrix environment required
  • Availability to travel up to ~20%, when necessary

Please send your resume to careers@cytrellis.com