Job Opportunity:
The Senior NPI Process Development Engineer will be a key member of an interdisciplinary team responsible for creating and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialization.
Responsibilities:
* Collaborate on cross-functional project teams to develop robust product designs ensuring capable manufacturing processes (Design for Manufacture).
* Evaluate critical quality requirements for components used in building complex acute ischemic stroke devices and translate these requirements into component specifications that guarantee manufacturability and consistent performance.
* Assess new and existing raw materials, components, and assembly suppliers for technical and manufacturing capabilities.
* Promote process/product improvements related to sub-assembly or component usage or design.
* Oversee 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 lines and pilot lines.
* Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place for components and finished devices.
* Identify project risks and develop mitigation strategies to ensure supply, quality, and timelines are met.
* Monitor supplier performance and provide technical support to resolve issues.
Requirements:
* 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.
* Understanding of product lifecycle and validation requirements for new product introduction.
* Experience in developing validation strategies for equipment or processes, including preparation of FMEAs protocols and reports.
Benefits:
This role offers a very competitive hourly rate.
About Us:
We strive to create an inclusive work environment where diverse backgrounds, perspectives, and experiences are valued and each team member feels they belong and can reach their full potential.