Cornell Dubilier - Manufacturer of Power Capacitors · 1 month 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 Corporation is a leading manufacturer of specialty electronic components, and they are seeking a highly skilled and experienced Staff Advanced Manufacturing Engineer to lead product and process development initiatives for innovative medical devices. This role is pivotal in bridging design and manufacturing, ensuring robust, scalable, and compliant production processes.
ElectronicsManufacturingProduct Design
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
Masters 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
Cornell Dubilier - Manufacturer of Power Capacitors
Cornell Dubilier was recently acquired by Knowles Corporation (NYSE: KN), a leading global supplier of high-performance components and solutions including capacitors and radio frequency (“RF”) filters, advanced medtech microphones, balanced armature speakers and audio solutions.
501-1000 employees
H1B Sponsorship
Cornell Dubilier - Manufacturer of Power Capacitors has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2023-09-18Acquired
Recent News
Google Patent
2025-02-17
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