Manager, Advanced Manufacturing Engineer - MedTech at Knowles Corporation

Itasca, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Advanced Manufacturing Engineering, Medical Device Manufacturing, Design for Manufacturability, Process Validation, Tooling Development, Statistical Analysis, CAD Tools, Regulatory Compliance, Continuous Improvement, Root Cause Analysis, Cost Analysis, Automation Strategies, Customer Collaboration, Quality Assurance, Six Sigma, Technical Leadership

Industry

electrical;Appliances;and Electronics Manufacturing

Description

Are you ready to play a key role in shaping the future of advanced manufacturing in the MedTech space? We are seeking a Manager, Advanced Manufacturing Engineering (AME) to drive product and process development for critical medical device components. This is a unique opportunity to work in a contract manufacturing environment where innovation meets execution—supporting world-class OEMs and scaling best-in-class solutions. Currently an individual contributor role, this position offers significant growth potential to build and lead a high-performing engineering team as our business continues to expand. If you thrive in a fast-paced, customer-focused setting and want to position yourself as a future MedTech leader, this role is for you. What You’ll Do Component Manufacturing Excellence * 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. Technical Leadership & Customer Interface * 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. Compliance & Validation * 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. What You Bring Required Qualifications * 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 Skills * 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. Why Join Us? * Opportunity to impact MedTech innovation at a component level, supporting top global OEMs. * Startup-like agility within a growing organization backed by strong industry presence. * Future leadership potential: Build and lead an engineering team as the business scales. * Competitive compensation and benefits package. EOE/M/F/D/V

Responsibilities

Lead the design, development, and optimization of manufacturing processes for precision medical device components. Collaborate with customers and internal teams to ensure compliance and drive continuous improvement initiatives.