Director of Manufacturing Engineering

Director of Manufacturing Engineering at The Judge Group Director of Manufacturing Engineering at The Judge Group in Saint Charles, Illinois Posted in 1 day ago.

Type:

full-time

Job Description:

Director of Manufacturing Engineering ????

Location:

Geneva, IL (On-site) ????

Compensation:

$135,000 - $140,000 annually ????

Reports to:

Chief Operations Officer (COO) About the Role Our client is seeking a driven and experienced Director of Manufacturing Engineering to lead our engineering organization across validation, production, and continuous improvement of innovative medical devices. This is a high-impact leadership role for someone who thrives at the intersection of hands-on manufacturing, regulatory excellence, and team leadership . You'll play a critical role in ensuring our products meet the highest quality standards while driving efficiency, scalability, and innovation. What You'll Do Lead Engineering & Innovation Build, lead, and develop cross-functional engineering teams Drive end-to-end manufacturing from concept through commercialization Foster a culture of continuous improvement and innovation Ensure Regulatory & Quality Excellence Maintain compliance with

FDA 21 CFR

Part 820 (cGMP) , ISO 13485 , and related standards Partner closely with Quality and Regulatory teams to ensure alignment throughout the product lifecycle Oversee design controls, risk management, validation, and testing Drive Manufacturing Performance Lead initiatives in lean manufacturing, automation, and design-for-manufacturability (DFM) Improve product quality, scalability, and cost efficiency Manage capital investments and automation projects Own Project Execution Deliver key engineering projects on time and within budget Communicate progress and insights clearly to senior leadership Oversee post-launch performance monitoring and continuous improvements Develop Talent & Culture Mentor and grow engineering talent Create a collaborative, high-performance team environment What We're Looking For Bachelor's or Master's degree in Biomedical, Mechanical, Industrial Engineering, or related field 5+ years of experience in manufacturing engineering within the medical device industry 3+ years of direct experience in medical device manufacturing environments Deep knowledge of

FDA 21 CFR

Part 820, ISO 13485, cGMP, and QMS Strong experience with validation, design controls, DFM, and cost reduction strategies Proven leadership experience managing engineering teams and cross-functional initiatives Hands-on mindset, comfortable spending significant time on the plant floor Operational Expertise Experience with machine efficiency, downtime reduction, preventive maintenance, calibration, and validation Track record of leading capital projects and automation investments Work Style Comfortable working in a blended role: 60% hands-on / 30% leadership / 10% administrative Willingness to travel up to 25% for vendor management, training, and leadership collaboration What Sets You Apart Deep hands-on experience in medical device manufacturing and sustaining engineering Expertise in validation, design transfer, and regulated manufacturing environments Exposure to medical textiles, R D, and quality engineering Experience with plating processes (non-electroplating) No relocation assistance provided. Must be able to commute to Geneva, IL daily. USA Citizenship or Green Card Required for consideration.

To apply:

Send updated resumes to MAhle@Judge.com #JDP