Knowles Precision Devices

Staff / Senior Staff Advanced Manufacturing Engineer, MedTech

Knowles Precision Devices

full-time

Posted on:

Origin:  • 🇺🇸 United States • Illinois

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Salary

💰 $112,000 - $170,000 per year

Job Level

Senior

About the role

  • Lead the development and implementation of manufacturing processes for new medical devices or components
  • Own Design for Manufacturability (DFM) and manage design transfer from R&D to production
  • Develop and optimize tooling, fixtures, automation strategies, and production workflows
  • Support Design Verification & Validation (DV&V) activities, including test method development
  • Conduct cost analysis for manufacturing including capital investments and make/buy decisions
  • Serve as the technical subject matter expert (SME) on cross-functional project teams
  • Collaborate with R&D, Quality, Regulatory, and Operations to ensure product performance and manufacturability
  • Engage with customers to communicate process capabilities, validation strategies, and DFM recommendations
  • Lead root cause investigations, corrective actions (CAPAs), and implement design or process improvements
  • Develop and execute IQ/OQ/PQ protocols for equipment and process validation
  • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable global regulations
  • Maintain documentation and traceability in alignment with design controls and quality systems

Requirements

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field. Masters preferred
  • 8–10+ years of experience in medical device design, manufacturing, or process engineering
  • Strong knowledge of: Medical device regulations (FDA, ISO 13485, EU MDR)
  • Strong knowledge of: Validation protocols (IQ/OQ/PQ)
  • Strong knowledge of: CAD tools (e.g., SolidWorks, Creo)
  • Strong knowledge of: Statistical tools (DOE, Minitab, Six Sigma)
  • Preferred: Experience with Class II or III implantable or disposable medical devices
  • Preferred: Hands-on expertise with manufacturing processes such as injection molding, laser welding, metal stamping, packaging, or sterilization
  • Preferred: Familiarity with design controls and PLM systems (e.g., Agile, Windchill)
  • Preferred: Certified Six Sigma Green/Black Belt or Certified Quality Engineer (CQE)
  • Strong written and verbal communication skills; capable of authoring technical reports, protocols, and presenting to stakeholders.