Engineer II, Manufacturing & Processing

Axogen•Vandalia, OH

3d•Onsite

About The Position

The Engineer II, Manufacturing/Processing Engineer position located in Dayton, OH will provide engineering and production support for Manufacturing Operations and New Product Development Teams to ensure new/improved and current medical products and processes are being produced in compliance with applicable standards and regulations.

Requirements

Bachelor’s Degree in Engineering or related discipline (Graduate degree preferred)
Two to four years’ experience in working as engineer in regulated industry
Demonstrated hands on technical skills
Ability to work with limited supervision

Nice To Haves

Preferred education focus in biomedical engineering, chemistry or biological sciences
Experience in tissue engineering and regenerative medicine products a plus (cleanroom processing, aseptic technique, tissue preservation, AATB standards)

Responsibilities

Supports Production on a day-to-day basis and ensures product is being released in a timely manner
Reprioritizes tasks as the needs of the company change
Provides focused technical/engineer support to Operations on manufacturing projects with an emphasis on capacity analysis, yield improvements, cost reduction, validations, implementing processes associated with new products and process improvements
Supports and collaborates with Research and Development and Quality Management on new product launches
Analyzes product and/or equipment specifications and performance requirements to determine feasibility of new plant equipment, or modifying existing equipment
Leads continuous improvement projects
Provides expertise and technical communications on quality issues
Provides cross-functional project management support to other areas of the business
Utilizes root cause analysis methods and statistical tools to resolve processing issues
Complies with all company policies, procedures, and SOP’s