Product Development Engineer

About the role

Product Engineering is responsible for transfer and scale-up of new products, developing iterations, modifying, implementing, and supporting existing products that function within the product families through adherence to established design control processes and good engineering practices.

Responsibilities

• Demonstrates advanced knowledge of Engineering principles in solving moderately complex problems.
• Demonstrates advanced knowledge of product design and development.
• Independently tests, analyzes, and solves technical problems.
• Applies advanced statistical techniques and utilizes design of experiments.
• Independently verifies design inputs and establishes appropriate design outputs and qualifies designs.
• Interfaces with and selects suppliers that meet technical criteria.
• Responsible for development and scale-up of new production lines ensuring the product follows applicable quality system regulations.
• Responsible for the maintenance of the Design History Files for the Infection Prevention products.
• Must have a working knowledge of Design Control for Medical Devices and Guidelines for Drug Development.
• Experience with Design Transfer, authoring and execution of protocols (IQ, OQ, PQ), Risk Management documents, creation of Manufacturing SOP, RMS, Batch Records, Inspection Plans, etc.

Requirements

• Bachelor's degree in Mechanical or Biomedical Engineering (preferred).
• A minimum of 2+ years of related work experience.
• Background in a highly regulated work environment required (Medical Device or Pharma strongly preferred).
• Experience working in a manufacturing environment.

Pay

$25–30/hr

Schedule

• 12-month contract.
• Start time: 7:00 AM, End time: 4:00 PM.
• 40 hours per week.