MedixTM
Manufacturing Engineering Manager (Direct Hire)
We are seeking a hands-on Manufacturing Engineering Manager to lead, mentor, and develop a team of talented engineers and technicians in a highly manual, precision-driven medical device manufacturing environment. This individual will play a key leadership role in optimizing production efficiency, driving continuous improvement, and implementing innovative solutions that enhance product quality and operational performance.
If you’re an experienced engineering leader with a strong background in manual manufacturing processes, validation (IQ/OQ/PQ), and a passion for mentoring teams while remaining hands-on with technical work — we want to hear from you.
Responsibilities:
- Lead, manage, and develop a team of 4–5 engineers, technicians, and machinists, fostering a culture of growth, accountability, and technical excellence.
- Provide technical guidance and mentorship to engineers and technicians, ensuring high performance and professional development.
- Develop and implement manufacturing processes, procedures, and equipment to optimize production efficiency, product quality, and operator safety.
- Collaborate cross-functionally with Design Engineering, Quality Assurance, and Production to introduce and validate new products and processes.
- Drive continuous improvement and Lean manufacturing initiatives to enhance productivity, reduce waste, and improve overall operational efficiency.
- Oversee validation activities (IQ/OQ/PQ) and ensure proper documentation and compliance with FDA, ISO, and internal quality standards.
- Evaluate, source, and implement new technologies, automation systems, and materials in collaboration with suppliers and vendors.
- Manage and track department budgets, cost controls, and capital expenditures.
- Serve as a working manager — leading by example, engaging directly with operators, and contributing to problem-solving on the production floor.
- Ensure compliance with safety, regulatory, and environmental standards while maintaining a culture of continuous learning and innovation.
Qualifications:
- 10+ years of experience in manufacturing or process engineering within the medical device industry (high-volume, low-cost product environment preferred).
- Hands-on experience working with manual manufacturing equipment.
- Strong understanding of validation protocols (IQ/OQ/PQ).
- Electrical engineering background (PCB layout experience preferred); ChemE or MechE considered with relevant manufacturing experience.
- Prior experience managing or leading a team — open to candidates with Lead Engineer or Supervisor experience who are ready for management.
- Proven ability to collaborate closely with production operators, not just fellow engineers.
- Excellent problem-solving, analytical, and interpersonal skills with the patience to work effectively across diverse teams.