Job Description:
Process Validation Engineer with 5+ years of engineering experience. This role includes an in-depth training program, where the consultant will be paired with a team member to review training materials and receive hands-on floor training related to process validation and supplier quality activities. The engineer will work cross-functionally to assess manufacturing and supplier quality processes, identify improvement opportunities, and implement effective solutions. Strong collaboration skills are essential, as the role requires partnering with R&D and the supplier engineering teams—experience with design for manufacturability is highly preferred to effectively communicate and resolve design-related issues. While catheter experience is not required, it is considered a strong plus.
Responsibilities:The ideal candidate will have a strong problem-solving mindset, able to take initiative and follow through on corrective actions. Familiarity with regulated environments and a solid understanding of validation protocols will be beneficial for success in this role.Process Validation, Supplier Quality, Manufacturing, Risk Management, Catheter or Capital Equipment experience.Design for Manufacturability, PFMEA, DFMEA, Electrical Engineering or Mechanical Engineering Background.Bachelor's in engineering.