Knowles Electronics, LLC.
Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech
Knowles Electronics, LLC., Itasca, Illinois, United States, 60143
Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - MedTech
Department:
Advance Manufacturing Engineering Employment Type:
Full Time Location:
Itasca, IL Reporting To:
Rich Scheleski Description
We are seeking a highly skilled and experienced
Staff Advanced Manufacturing Engineer (AME)
to lead product and process development initiatives for innovative medical devices (Class I, II, or III). This role is pivotal in bridging design and manufacturing, ensuring robust, scalable, and compliant production processes. The ideal candidate will bring deep technical expertise, cross-functional leadership, and a strong understanding of regulatory requirements in the MedTech space. Key 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. Skills, Knowledge and Expertise
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 (e.g., 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 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. Pay Parency and Benefits
At Knowles, we strive to deliver a Total Rewards package that will attract, engage, and retain top talent. The salary range for this position is $112,000.00/yr - $170,000.00/yr. This is a good faith estimate on the applicable range and serves as a general guideline. We recognize that candidates will come to us with different sets of skills and experiences. Therefore, the offer will be determined more or less than the anticipated range after considering various factors, including but not limited to the scope and responsibilities of the position, the candidate’s experience, education, skills and abilities as well as internal equity and alignment with market data. Certain roles may be eligible for other compensation and benefits programs. Benefits and other Compensation Programs At Knowles, we strive to deliver a market competitive compensation and benefits programs that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities. The specific programs and options available to any given employees may vary depending on eligibility factors such as geographic location, date of hire, candidate experience and qualifications as well as market and business considerations. We also provide eligible employees with an opportunity to enroll in a variety of benefit programs, generally including medical, dental and vision insurance, a 401(k) plan with a company match, short-term and long-term disability coverage, life insurance and wellbeing benefits, among others. Below is a summary of common benefits that Knowles provides to employees (eligibility requirements apply): 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) EOE/M/F/D/V
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Department:
Advance Manufacturing Engineering Employment Type:
Full Time Location:
Itasca, IL Reporting To:
Rich Scheleski Description
We are seeking a highly skilled and experienced
Staff Advanced Manufacturing Engineer (AME)
to lead product and process development initiatives for innovative medical devices (Class I, II, or III). This role is pivotal in bridging design and manufacturing, ensuring robust, scalable, and compliant production processes. The ideal candidate will bring deep technical expertise, cross-functional leadership, and a strong understanding of regulatory requirements in the MedTech space. Key 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. Skills, Knowledge and Expertise
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 (e.g., 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 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. Pay Parency and Benefits
At Knowles, we strive to deliver a Total Rewards package that will attract, engage, and retain top talent. The salary range for this position is $112,000.00/yr - $170,000.00/yr. This is a good faith estimate on the applicable range and serves as a general guideline. We recognize that candidates will come to us with different sets of skills and experiences. Therefore, the offer will be determined more or less than the anticipated range after considering various factors, including but not limited to the scope and responsibilities of the position, the candidate’s experience, education, skills and abilities as well as internal equity and alignment with market data. Certain roles may be eligible for other compensation and benefits programs. Benefits and other Compensation Programs At Knowles, we strive to deliver a market competitive compensation and benefits programs that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities. The specific programs and options available to any given employees may vary depending on eligibility factors such as geographic location, date of hire, candidate experience and qualifications as well as market and business considerations. We also provide eligible employees with an opportunity to enroll in a variety of benefit programs, generally including medical, dental and vision insurance, a 401(k) plan with a company match, short-term and long-term disability coverage, life insurance and wellbeing benefits, among others. Below is a summary of common benefits that Knowles provides to employees (eligibility requirements apply): 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) EOE/M/F/D/V
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