The Production Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. The Production Engineer works with Operations, Quality Assurance and Regulatory Affairs to improve existing product designs and processes to increase throughput, decrease operational costs, or improve quality.
Lead or assist in CAPA investigations and implementations.
Develop, maintain, improve manufacturing and inspection processes/procedures.
Perform equipment and process validations and testing to internal procedures and/or external standards.
Develop cleanliness and environmental control processes and procedures.
Define equipment maintenance requirements.
Design and improve manufacturing and inspection equipment.
Assist with training manufacturing and QC operators, procurement, resolving issues with suppliers.
Assist with equipment instrument calibrations, performing process failure mode effects analyses and repairing equipment and tooling.
Work with Operations Managers and outside Vendors to create methods/machines to help with capacity of products.
Work with Product Development Engineers to develop processes for new products.
Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.
Must maintain a positive and professional representation of the company.