Engineer II, Process

POSITION SUMMARY:

Responsible for developing, characterizing and validating manufacturing processes to produce biochemical assay plates and related consumables.

DUTIES AND RESPONSIBILITIES: 

• Review existing manufacturing processes to determine if changes are needed to improve quality and quantity of products, reduce any variations between lots produced and expand product portfolio.

• Make recommendations to manager to improve/enhance processes as needed.

• Design and conduct process experiments on manufacturing and pilot scale equipment to determine if/how changes affect product(s) properties.

• Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials.

• Collaborate with other departments to determine if improvements are needed to enhance product performance.

• Support the corporate validation effort as required for ISO certification and FDA approval.