Chemical Engineer II

Cretex•Coon Rapids, MN

3d•$75,000 - $110,000•Onsite

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

Benefits

medical
dental
vision
life insurance options
401(k) retirement plan with employer match
profit sharing
short- and long-term disability insurance
paid time off
holiday pay
onsite medical clinic
Onsite Clinic
Paid Parental Leave
Monthly Social Events
Annual Employee Appreciation Week
Volunteer Opportunities
Training and Development Opportunities
Tuition Reimbursement
Wellness Program
Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.
Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.
Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.