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