Key Skills for Senior Process Engineer Role
Are you a detail-oriented professional with experience in medical device process design and development?
* Process Design Expertise:
* Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices.
* Translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.
About the Job
This role involves work collaboratively on cross-functional project teams to develop robust product designs ensuring capable manufacturing processes.
* Drive process/product improvements related to sub-assembly or component usage or design.
* Manage prototype builds to support characterization and develop assessment strategies.
* Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing line and pilot lines.
Requirements:
* Technical Expertise:
* Strong understanding and proven experience using appropriate statistical tools throughout each project lifecycle stage.
* High level of technical writing and reporting skills.
* Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC).
Qualifications:
* Degree in Mechanical or Biomedical Engineering or equivalent.
* At least 5-7 years of medical device process/device design and development experience in a regulated environment.
* Prior experience in medical device catheter process design and/or manufacturing is highly desirable.