Knowles Precision Devices · 1 week ago
Manager, Advanced Manufacturing Engineer - MedTech
Itasca, IL
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKnowles Precision Devices is seeking a Manager, Advanced Manufacturing Engineering (AME) to drive product and process development for critical medical device components in the MedTech space. This role involves leading the design and optimization of manufacturing processes, collaborating with various teams to ensure compliance with medical device standards, and contributing to long-term strategies for advanced manufacturing technologies.
ElectronicsIndustrial EngineeringManufacturing
Responsibilities
Lead the design, development, and optimization of manufacturing processes for precision medical device components (Class I, II, III)
Drive Design for Manufacturability (DFM) and ensure smooth design transfer from customer R&D to our production floor
Develop advanced tooling, fixtures, and automation strategies to enhance process capability and efficiency
Partner with customers on process validation, capability studies, and technical discussions to align manufacturing solutions with device requirements
Perform cost analysis, capital planning, and support make/buy recommendations to ensure scalability and profitability
Serve as the technical SME for internal teams and customer-facing discussions, presenting process capabilities and validation strategies
Collaborate closely with Quality, Operations, and Regulatory teams to ensure compliance with medical device standards
Lead root cause analysis, corrective actions (CAPAs), and continuous improvement initiatives to exceed customer expectations
Contribute to long-term strategy for advanced manufacturing technologies and future team development
Author and execute IQ/OQ/PQ protocols for equipment and process validation
Ensure all activities align with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations
Maintain detailed documentation to support design controls and customer audits
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related technical field (Master's preferred)
8–10+ years in medical device manufacturing or process development, ideally within a contract manufacturing or component-level environment
Expertise in: Medical device regulatory standards (FDA, ISO 13485, EU MDR)
Validation (IQ/OQ/PQ) and process capability analysis
CAD tools (SolidWorks, Creo)
Statistical tools and methodologies (DOE, Minitab, Six Sigma)
Preferred
Experience working with OEMs on component-level manufacturing for Class II/III devices
Hands-on knowledge of processes such as precision machining, injection molding, laser welding, or cleanroom assembly
Familiarity with design controls and PLM systems (Agile, Windchill)
Six Sigma Green/Black Belt or CQE certification preferred
Exceptional communication skills and ability to influence internal and external stakeholders
Benefits
Competitive compensation and benefits package.
Company
Knowles Precision Devices
Knowns Precision Devices is a manufacturer of microelectronic components.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
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