Director of Manufacturing/Engineering

Director of Manufacturing Engineering

This position will ensure that all products meet regulatory standards, adhere to the highest quality controls, and align with the needs of both the business and customers. This position requires an expert in medical device manufacturing, with a strong track record of problem solving, project management, and leadership.

As a Manufacturing Engineering Director your responsibilities will include:

• Lead and develop cross‑functional engineering teams to drive innovation, continuous improvement, and end‑to‑end manufacturing of medical devices from concept through production.
• Ensure full compliance with FDA 21 CFR Part 820 cGMP, ISO 13485, and related regulatory requirements across the manufacturing lifecycle, partnering closely with Quality and Regulatory.
• Own manufacturing development and validation activities, including design controls, risk management, testing, and process validation.
• Drive operational excellence through lean manufacturing, automation, and design‑for‑manufacturability initiatives to improve quality, scalability, cost, and efficiency.
• Deliver projects on time and within budget while providing clear communication to senior leadership, leading post‑launch performance monitoring, and mentoring engineering talent.

The Manufacturing Engineering Director position may be right for you if you:

• You thrive in leadership roles, guiding cross‑functional engineering teams to deliver innovative, continuously improving medical device manufacturing solutions from concept through production.
• You bring deep regulatory and validation experience, confidently ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and overseeing risk management, design controls, and testing.
• You are energized by engineering improvement, driving lean manufacturing, automation, and design‑for‑manufacturability to improve scalability, quality, and cost efficiency.
• You excel at project leadership, balancing engineering rigor with business needs while delivering projects on time, on budget, and with clear communication to senior stakeholders.
• You take ownership beyond launch, leading post‑production performance monitoring, root cause analysis, and ongoing design and process enhancements.
• You are passionate about people and collaboration, mentoring engineers, fostering a culture of learning and innovation, and partnering closely with Quality and Regulatory teams to ensure alignment.
• Have proven successful experience in capital expenditures and automation investment projects. 

. Qualified candidates will have:

• Bachelor’s or master’s degree in biomedical engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• 5+ years of experience with manufacturing processes, design for manufacturability (DFM), and cost reduction strategies in the medical device industry.
• At least 3 years of experience in the manufacturing of medical devices and a strong understanding of FDA 21 CFR Part 820 cGMP, ISO 13485, and other applicable standards.
• Experience with machine efficiency, down time, preventative maintenance, calibrations, validation, QMS (Quality Management Systems) and regulatory adherence. 
• Energized and comfortable to work in 10% administration, 30% leadership, and 60% hands-on in the plant environment.
• Additional travel of 25% for training, vendor management or leadership meetings is also required.                                                                                                                                     

     Candidates must currently be USA Citizen or Green Card Holder. Work visa sponsorship is not available for this role.

What will set you apart:

• Technical, hands-on manufacturing experience expertise, validations, design control/transfer.
• Regulated medical industry experience and sustaining engineering 
• Experience with plating (not electroplating) 
• Experience with medical textile, R&D, design control, and quality engineering. 

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