Materials Engineer II (Polymers)
Education Required: Bachelors Degree required but advanced degree will be preferred.
Description:
This position will work in a team environment supporting product and materials development with a focus on released product. The candidate will be part of a team ensuring product safety and reliability through the direction and execution of characterization testing and assessment as well as assessment of changes impacting materials. This will include providing problem solving, materials laboratory testing and data analysis in support of new and existing implantable biomedical devices and systems. Biocompatibility, Materials of Concern, and biostability testing, as well as documenting product equivalence through appropriate characterization testing will also be included.
Additional responsibilities include providing materials engineering support to document product compliance with international biocompatibility and supporting regulatory submission. Primary areas of focus include testing materials for reliability, stability, and compliance with other regional standards for medical devices.
This person will work under general supervision, solving technical problems in cardiac therapy with an emphasis on materials and materials analysis.
Duties:
- Conduct laboratory testing and write technical reports to document device/component compliance with necessary regulations and materials characterization requirements.
- Work in a regulated environment.
- Support regulatory submissions with technical rationales/documentation on an as needed basis.
- Communicate results and strategies via detailed technical documents and presentations.
- Support the quality and reliability of released product through comparative testing or root cause characterization testing.
- Participate in the analysis of technical issues and the development of recommendations for project decisions and actions
- Possesses experience in the following business-critical skill sets:
- Materials Characterization of Metallic, Ceramic, or Polymeric Components
- Mechanics of Materials
- Assessment of Materials of Concern
- Fatigue testing
- Maintains a focus on quality, possesses the necessary drive and determination to promote the highest level of customer satisfaction, quality, reliability, performance, cost, and development predictability.
- Contributes to the design of new products or processes based on business strategy.
Required Qualifications:
- Bachelor's Degree
- 1+ years of relevant experience with a Bachelor’s Degree in material science, metallurgy, ceramics or related field
- Advanced Degree with little/no experience welcomed
Preferred Qualifications:
- Experience in materials with the ability to identify testing methods to correlate material properties with product performance.
- Experience in manufacturing and/or development.
- Working knowledge of multiple classes of engineering materials: metals, polycrystalline, and single crystal ceramics, glasses, and polymeric materials.
- Experience performing failure analysis
- Demonstrated ability to deliver quality technical work within project schedules and timelines.
- Knowledge of regulations related to Biocompatibility, Materials of Concern, and Hazardous Substances (e.g. RoHS, EU MDR, California Prop. 65, ISO 10993)
- Knowledge of statistical methods and Design of Experiments (DoE) using Minitab.
- Knowledge of Microsoft applications (Excel, Word, Outlook).
