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Knowles Corporation · 2 weeks ago

Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech

Itasca, IL

Full-time

Onsite

Senior Level, Lead/Staff

$112K/yr - $170K/yr

8+ years exp

Knowles Corporation is seeking a highly skilled and experienced Staff Advanced Manufacturing Engineer (AME) 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.

Electrical & Electronic Manufacturing

H1B Sponsor Likely

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

Medical device regulationsValidation protocolsCAD toolsStatistical toolsDesign controlsSix Sigma certificationManufacturing processesCommunication skills

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

Knowles Corporation

Glassdoor3.8

Knowles is a leading manufacturer of specialty electronic components.

Founded in 1946

Itasca, Illinois, US

10001+ employees

http://www.knowles.com

H1B Sponsorship

Knowles Corporation 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

2025 (3)

2024 (8)

2023 (6)

2022 (12)

2021 (9)

2020 (18)