Knowles Corporation
Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech
Knowles Corporation, Itasca, Illinois, United States, 60143
Overview
Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech is a role that leads product and process development initiatives for innovative medical devices (Class I, II, or III). This position bridges design and manufacturing to ensure robust, scalable, and compliant production processes. The ideal candidate brings deep technical expertise, cross-functional leadership, and a strong understanding of regulatory requirements in the MedTech space. Responsibilities
Product & Process Development
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.
Technical Leadership
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.
Validation & Compliance
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.
Qualifications
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); validation protocols (IQ/OQ/PQ); CAD tools (SolidWorks, Creo); statistical tools (DOE, Minitab, Six Sigma). Preferred Skills & Experience: experience with Class II or III implantable or disposable medical devices; hands-on expertise with 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 CQE; strong written and verbal communication skills for technical reports, protocols, and stakeholder presentations. Pay Parity and Benefits
Salary range for this position is $112,000.00/yr - $170,000.00/yr. This is a good faith estimate and the offer will consider factors such as scope and responsibilities, experience, education, skills, internal equity, and market data. Some roles may be eligible for other compensation and benefits programs. Benefits and other compensation programs include market-competitive base pay and variable compensation opportunities. Benefits commonly include medical, dental, and vision insurance; 401(k) with company match; disability coverage; life insurance; and wellbeing programs. Eligible employees may enroll in benefit programs which may include: medical/dental/vision, HSA/FSA, 401(k) with company match, disability coverage, life insurance, and EAP. EOE/M/F/D/V Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries: Appliances, Electrical, and Electronics Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech is a role that leads product and process development initiatives for innovative medical devices (Class I, II, or III). This position bridges design and manufacturing to ensure robust, scalable, and compliant production processes. The ideal candidate brings deep technical expertise, cross-functional leadership, and a strong understanding of regulatory requirements in the MedTech space. Responsibilities
Product & Process Development
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.
Technical Leadership
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.
Validation & Compliance
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.
Qualifications
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); validation protocols (IQ/OQ/PQ); CAD tools (SolidWorks, Creo); statistical tools (DOE, Minitab, Six Sigma). Preferred Skills & Experience: experience with Class II or III implantable or disposable medical devices; hands-on expertise with 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 CQE; strong written and verbal communication skills for technical reports, protocols, and stakeholder presentations. Pay Parity and Benefits
Salary range for this position is $112,000.00/yr - $170,000.00/yr. This is a good faith estimate and the offer will consider factors such as scope and responsibilities, experience, education, skills, internal equity, and market data. Some roles may be eligible for other compensation and benefits programs. Benefits and other compensation programs include market-competitive base pay and variable compensation opportunities. Benefits commonly include medical, dental, and vision insurance; 401(k) with company match; disability coverage; life insurance; and wellbeing programs. Eligible employees may enroll in benefit programs which may include: medical/dental/vision, HSA/FSA, 401(k) with company match, disability coverage, life insurance, and EAP. EOE/M/F/D/V Seniority level
Mid-Senior level Employment type
Full-time Job function
Engineering and Information Technology Industries: Appliances, Electrical, and Electronics Manufacturing We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr