Knowles Precision Devices · 4 months ago
Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech
Itasca, IL
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $170K/yr
8+ years expKnowles Precision Devices is a leading manufacturer of specialty electronic components, focusing on innovative technologies in various sectors including MedTech. They are seeking a Staff Advanced Manufacturing Engineer to lead product and process development for medical devices, ensuring robust and compliant production processes while collaborating with cross-functional teams.
ElectronicsIndustrial EngineeringManufacturing
Responsibilities
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
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field
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
Hands-on expertise with manufacturing processes such as injection molding, laser welding, metal stamping, packaging, or sterilization
Familiarity with design controls and PLM systems (e.g., Agile, Windchill)
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
Benefits
Medical, dental and vision
Health Savings Account (HSA) / Flexible Spending Accounts (FSA)
401K plan with a company match - 100% match on the first 5% you contribute
Short- and Long-term disability coverage
Life Insurance and AD&D - 100% paid by employer
Employee Assistance Program (EAP)
Company
Knowles Precision Devices
Knowns Precision Devices is a manufacturer of microelectronic components.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
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