Manufacturing Engineer

04 Dec 2024

Vacancy expired!

Manufacturing EngineerSan diego, CA

  • Manufacturing process Development and management of a transition plan and team Process documentation transfer.
  • Coordination & preparation Equipment moves/ setup and installation
  • Technical writing of protocols, Engineering tests as per medical device part 21 CFR Quality system
  • IQ, OQ, PQ protocol development and execution support Production startup and training support.
  • Is required develop technical documentation in medical device product development such as Buyspecs, Manufacturing procedures, Test methods etc.
  • Is required to develop/author medical device development validation plans, test protocols etc and independently required to execute them as well.
  • Work within medical device Quality system ISO13485 for execution of change controls and Design control activities
  • Is required to setup/update ERP system related to new medical device product.
  • Creation of documents, master data etc.
  • Demonstrated proficiency in equipment and tooling procurement and process design and development (assembly and associated process development)
  • Follow-up with Work Stream Leads from medical device Manufacturing Plants and to assimilate project information daily
  • Understanding and ability to execute DOEs, process validations and process characterizations for medical device process development
  • Creates and reviews risk assessments and FMEA
  • Oversees and is accountable for overall compliance administration activities relating to QSR, design controls, validations and CAPA
  • Provides support for project teams or Quality department as required.
  • Provides work direction as required.
  • Creates and reviews quality system documentation.
  • Maintains validation master plan.
  • Builds protocols, test methods, Product validations
  • Performs supplier quality system audits.
  • Strong interpersonal skills required in the areas of verbal and written communications, time management and professionalism
  • Strong information management skills.
  • Strong analytical thinking, questioning & problem-solving skills.

  • ID: #23852571
  • State: California San diego 92101 San diego USA
  • City: San diego
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2021-12-04
  • Deadline: 2022-01-31
  • Category: Et cetera