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Senior/Principal R&D Process Engineer

Company: Galvanize Therapeutics, Inc.
Location: Pomona
Posted on: August 1, 2022

Job Description:

Job Description:

  • The R&D Principal Process Engineer works with Quality, Operations, Accounting and Supply Chain in the development, implementation and improvement of processes related to manufacturing and inspection of medical devices.
  • Collaborate in the design and development of new products, materials, manufacturing processes, & equipment
  • Responsible for timely project completion. Designs experiments and documentation independently. May mentor interns and/or junior engineers.
  • Work with design engineers during product development phase to incorporate DFM concepts and strategies
  • May act as lead manufacturing/process engineer. Provides technical direction and feedback to others.
  • Assist in the transfer of new products from R&D to production.
  • Establish processes and manufacturing documentation for new catheter products.
  • Identify processes to fabricate new products.
  • Design and development of tooling. Use CAD software (Solidworks preferred) for jigs and fixtures design with detailed drawings.
  • Develop and conduct Verification and Validation activities for all manufacturing processes, to include IQ\OQ\PQ and manage equipment qualification.
  • Develop and maintain Manufacturing Process Validation Plan.
  • Coordinate with the Quality Department on the development and execution of Test Method Validations.
  • Interact with vendors to select and purchase equipment, fixtures, tooling and tools to support manufacturing processes.
  • Develop, maintain, and improve manufacturing and inspection processes and procedures.
  • Initiate equipment modifications to improve productivity and product quality.
  • Assist with repairing equipment and tooling.
  • Assist with performing process failure mode effects analyses.
  • Developing and implementing manufacturing process control and performance monitoring
    Qualifications:
    • Bachelor's Degree in biomedical or mechanical or electrical engineering
    • Minimum Ten (10) years of experience working in the medical device industry
    • Knowledge of FDA/MDD regulations as they relate to Class III medical devices
    • Demonstration of excellent communication skills (written and oral)
    • Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
    • Expert on mechanical tolerancing, and blueprints, and familiarity with CAD modelling software (Solidworks preferred).
    • Knowledge of FDA regulated manufacturing environment, including validations (IQ, OQ, PQ), quality systems, and ISO/GMP standards.
    • Experience in the design, development and assembly of jigs, fixtures and set up manufacturing line.
    • Strong analytical and problem-solving skills are necessary.
    • Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross-functional activities and issues are necessary.
    • Experienced in design of experiments, structured problem solving and validation.
    • Experience with determining Root Cause and Corrective Action implementation
    • Ability to travel up to 10% of the time.

Keywords: Galvanize Therapeutics, Inc., Pomona , Senior/Principal R&D Process Engineer, Accounting, Auditing , Pomona, California

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