Sr. Advanced Manufacturing Engineer; AME - MedTech

Staff / Sr. Staff Advanced Manufacturing Engineer (AME) - Med Tech

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Department: Advance Manufacturing Engineering

Location: Itasca, IL

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 Med Tech space.

• 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.

• 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., Solid Works, Creo), and 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.

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 $/yr - $/yr. Certain roles may be eligible for other compensation and benefits programs.

Benefits include medical, dental, and vision insurance;
Health Savings Account (HSA)/Flexible Spending Accounts (FSA); 401K plan with a company match; short‑ and long‑term disability coverage; life insurance and AD&D; and employee assistance program.

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