Principal Engineer, Material Science
Principal Engineer – Material Science at ICU Medical will be involved in selection and analytical analysis of polymeric materials for new product development and for on – market troubleshooting. Principal Engineer will work collaboratively with cross functional team in selecting/ recommending biocompatible polymeric materials and elastomers for the proposed designs using principles of polymer science, structure property co-relationship, and biomaterials engineering. Additionally, it is the Principal Engineer’s responsibility to clearly communicate the strength and limitations of the selected materials for including but not limited to – compliance to applicable regulations, chemical compatibility, biocompatibility, product design, and manufacturing processes.
Essential Duties & Responsibilities
- Work as a core team lead on moderate to high complexity projects.
- Write white papers using test data and published literature to support regulatory requirements.
- Develop qualification plan, test methods, and characterization techniques for material selection.
- Interpret material chemical compatibility with drug formulations.
- Predict material performance based on chemical compatibility, bio-compatibility, extractable & leachable requirements, and sterilization methods.
- Interpret user needs and design inputs to meet processing requirements and end user needs.
- Write project summary report, design verification & validation report, and material selection rationale report.
- Lead Root Cause Analysis and CAPA investigations.
- Responsible for sourcing materials for pre-concept/ concept phase device development.
- Evaluate analytical data to determine compliance with establishes specifications.
- Adhere to cGMP's, SOP's and company policies/guidelines.
- Assist in document control and maintenance of design history file. Create specification, reports and bill of materials
Knowledge, Skills & Qualifications
- Five to eight years of experience in Research and Development or related area.
- Fundamental knowledge of chemistry/ chemical Engineering with specialization in Materials Science and Engineering, Polymer Science and Engineering, or Biomaterials.
- Advanced knowledge of Polymer Science, Polymer synthesis, Characterization, blends development, extrusion, molding, composite formulation etc.
- Excellent verbal and written communications skills
- Good understanding of business needs
- Exceptional interpersonal skills; professional demeanor and attitude.
- Good negotiating skills
- High level of attention to detail
- Ability to prioritize key business objectives and respond quickly to changing priorities
- Ability to work independently with minimal to no daily instruction
- Able to multitask and work in a fast-paced environment
Education and Experience
- Bachelor’s degree from an accredited college or university is required, Masters or Ph.D. preferred
- Minimum 5-7 years of experience
- Typically requires travel less than 15% of the time
Physical Requirements and Work Environment
- This job operates in a laboratory and office environment.
- Must be able to occasionally move and lift objects of up to 25 lbs. – carrying/ moving boxes of test samples.