Seeking Manufacturing Engineer in San Diego, CA

15 Nov 2024

Vacancy expired!

Position: Manufacturing Engineer Location: San Diego, CA Duration: 06 Months+ Job Description:

  • Primarily responsible for engineering support for manufacturing operations and Mfg. quality activities to at the site.
  • Proven experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results.
  • Proven Mfg. plant medical device product and process development experience owning and driving projects to fruition, with a proven work ethic and consistently exceeding results
  • Plan, coordinate and manage all manufacturing activities associated with commercialization and launch of new medical device and pharmaceutical products.
  • Medical device 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.
    • 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.
    • General quality control and compliance
QUALIFICATIONS
  • Expertise working in medical device manufacturing plant for medical/ pharma industry.
  • Expertise in medical device technical writing of protocols, validation plans etc
  • 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.
EDUCATION and/or EXPERIENCE
  • Minimum undergraduate degree (BS) in Science, Mechanical/Industrial/Biomedical engineering
  • 4Years of medical device product and process development experience in a manufacturing plant setting

  • ID: #22804371
  • State: California San diego 92108 San diego USA
  • City: San diego
  • Salary: USD 40/hr W2 All Inc 40/hr W2 All Inc
  • Job type: Contract
  • Showed: 2021-11-15
  • Deadline: 2022-01-13
  • Category: Manufacturing