Chemical Engineer II

rms Company•Coon Rapids, MN

5d•$75,000 - $110,000

About The Position

The Chemical Engineer II will be responsible for designing, implementing and optimizing chemical processes and systems. Will work on various projects from improving existing processes to developing new ones. This position will collaborate with cross functional teams to ensure that processes meet safety, quality and efficiency standards.

Requirements

Bachelor’s Degree in Biochemistry, Chemical Engineering or related field
5+ years of industry experience in a medical device or semi conductor manufacturing setting
Ability to work in a manufacturing environment
Knowledge of cleaning, passivation, electropolishing processes, and electrochemistry for a variety of metal alloys
Knowledgeable in local, state and federal chemical management regulations and safety requirements
Ability to prepare chemical solutions, standards, and use common laboratory and chemical processing equipment
Experience with acid/base chemistry and solvents
Experience with validation design and execution with the IQ/OQ/PQ approach
Ability to tolerate ambiguity, multiple priorities and short deadlines

Nice To Haves

Working Knowledge of standards such as: ISO 10993-5, 10993-7, 10993-18, USP 788, ISO 11737-1, USP 85, USP 232, USP 643, USP 1231, and other medical device relevant specifications.
Experience with compliance regulations: REACH, RoHS, EU MDR, Prop 65, PFAS, Animal Derivatives, CMRT, and EMRT.
Hands-on experience with machines such as: TOC analyzers, ICP-MS, UV-Vis Spectrometry, gravimetric residue analysis, Bioburden Vacuum filtration. agar plating, and GC.
Familiarity of cleanroom classifications and compliance requirements.
Experience with chemical management systems.
Familiarity with maintaining high purity water systems for medical device cleaning per USP 1231.

Responsibilities

Lead or assist in completing new or improved chemical cleaning, passivation and electropolishing processes and next generation programs to meet strategic goals and objectives for the company
Support the maintenance of all chemical baths and equipment throughout the manufacturing facility
Provide technical guidance and support for troubleshooting and resolving process issues
Collect and analyze data required to monitor process performance and make improvements and/or modifications
Follow correct methods and practices of chemical handling, storage, and disposal
Write technical reports or prepare graphs and charts to document experimental results
Perform chemical analysis and process monitoring as appropriate
Perform customer, equipment, and process validations
Perform and/or support process validations as required with an IQ/OQ/PQ approach
Maintain and update the facility master validation plan
Develop and maintain various chemical process related work instructions
Create documentation for fixture design
Support and comply with the company Quality System, ISO, and medical device requirements
Read, understand, and follow work instructions and standard work