Coatings Chemist

Integer•Chaska, MN

2d•Onsite

About The Position

Conducts coating chemistry work related to the manufacture, scale-up, control, and continuous improvement of hydrophilic coatings for catheters and guidewires. Ensures consistent execution of validated coating processes to meet safety, quality, and delivery targets in a production environment. Investigates and resolves polymer- and coating-related technical issues that affect product performance and yield while partnering closely with Operations, Quality, and Engineering teams to support commercial production.

Requirements

Bachelor’s degree in Chemistry, Polymer Science, Materials Science, or related field
0–3 years of experience in a manufacturing, process chemistry, or coatings environment
Technical Expertise: Chemical process execution (mixing, coating, curing, cleaning, scale-up)
Analytical techniques: HPLC/UPLC, FTIR, UV-Vis, rheology, friction testing
Process monitoring and control systems (SPC, MES, batch execution)
Validation methodologies (IQ/OQ/PQ), MSA/Gage R&R
Quality & regulatory standards (ISO 13485, FDA, CAPA)
Strong troubleshooting ability in real-time production environments
Ability to work on the manufacturing floor with cross-functional teams
Data analysis and problem-solving skills
Polymer chemistry and hydrophilic coating systems
Manufacturing scale-up and process robustness principles
Continuous improvement methodologies (Lean, Six Sigma preferred)

Responsibilities

Execute established coating formulations and processes in adherence to validated parameters and specifications
Provide hands-on support for coating, mixing, curing, and surface preparation processes
Perform routine analytical and in-process testing to ensure materials and finished goods meet specifications
Monitor product performance through data trending and process verification
Investigate deviations, nonconformances, and yield issues using root cause analysis tools
Partner with Operations, Engineering, and Quality to ensure processes are scalable, safe, and capable
Optimize polymer chemistry operations (mixing, dispersion, curing, coating, drying, cleaning) for throughput, yield, and robustness
Author and maintain SOPs, specifications, batch records, BOMs, routers, and work instructions
Support validation activities including IQ/OQ/PQ and MSA/GR&R to sustain validated production processes
Execute complex batch records and troubleshoot real-time production issues (e.g., low yield, OOS/OOT results)
Define raw material specifications and collaborate with Supplier Quality on material consistency and change control
Evaluate and disposition nonconforming materials and implement CAPA and risk mitigations
Ensure adherence to QMS and regulatory standards (FDA 21 CFR Part 820, ISO 13485)
Apply GLP/GMP, ALCOA+ data integrity, and safe chemical handling practices
Support complaint investigations, failure analysis, and trend reduction activities
Drive process improvements focused on yield, cost, cycle time, and capability (Cp/Cpk)
Participate in cross-functional initiatives to enhance manufacturability and efficiency
Support and contribute to Integer Production System initiatives: Strategy alignment through Hoshin planning and SIOP, Sustained change via production performance monitoring, Standardization through manufacturing work instructions and training, Engagement in safety and problem-solving systems, Optimization of systems, process flow, and equipment reliability