Sr. Advanced Manufacturing Engineer; AME - MedTech

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

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.

Department:
Advance Manufacturing Engineering |

Employment Type:

Full Time |

Location:

Itasca, IL | Workplace type:
Onsite | Reporting To:
Rich Scheleski

• 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 (Master’s preferred).
• 8–10+ years of experience in medical device design, manufacturing, or process engineering.
• Medical device regulations (FDA, ISO 13485, EU MDR).
• Validation protocols (IQ/OQ/PQ).
• CAD tools (e.g., Solid Works, Creo).
• Statistical tools (DOE, Minitab, Six Sigma).
• 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.

Salary Range: $112,000 – $170,000 per year (estimation). Variable compensation opportunities and other benefits applicable.

Benefits include:

• Medical, dental, vision.
• Health Savings Account (HSA) / Flexible Spending Accounts (FSA).
• 401(k) plan with 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