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
Didn't find what you're looking for? Search again!
Loading more jobs...