Engineering Manager

The Manufacturing Engineering Manager leads all engineering activities that support the production of medical devices and other products in a small, fast-moving company environment. This role blends strategic leadership with hands‑on technical work, ensuring products are manufactured safely, efficiently, and in compliance with FDA, ISO 13485, and ISO 9001 requirements. The ideal candidate thrives in a setting where they can influence processes end‑to‑end and collaborate closely with R&D, Quality, and Operations.

The Manufacturing Engineering Manager leads the plant engineering team responsible for all technical aspects of the plant. This includes manufacturing engineering, manufacturing/molding technicians, design transfer projects, machine shop, continuous improvement, and facilities. This person also serves as the Company Safety Officer and ensures safety compliance.

A core responsibility will be in automating production processes to realize targeted cost reduction goals.

This role blends hands‑on technical leadership with people management, ensuring that products produced meet all quality/regulatory requirements and company goals. The ideal candidate thrives in a fast‑moving, resource‑conscious environment and enjoys building processes, teams, and products from the ground up while also having the ability to roll up their sleeves to lead technical projects.

The Manufacturing Engineering Manager reports to the Director of Plant Operations, is a member of the Plant Leadership Team and the Company Extended Leadership Team.

• Own the manufacturing engineering function, including process development, equipment selection, and continuous improvement.
• Build and maintain scalable manufacturing processes suitable for a small but growing operation.
• Lead root‑cause investigations and corrective actions for production issues.
• Ensures all equipment is designed and maintained to ensure safety.
• Responsible for extrusion, injection molding, converting area, and machine shop.
• Own the continuous improvement and cost reduction programs including the Kaizen program.

• Develop, validate, and document manufacturing processes (IQ/OQ/PQ).
• Implement lean manufacturing principles to reduce waste and improve throughput.
• Create and maintain work instructions, process flow diagrams, and PFMEAs.

• Provide daily technical support to production teams.
• Troubleshoot equipment, tooling, and process issues.
• Train operators and technicians on new processes and equipment.
• Ensures equipment performs per‑standard to achieve on time delivery of customer orders.
• Owns preventative maintenance.

• Ensure all manufacturing activities comply with FDA 21 CFR 820, ISO 13485, ISO 9001, and internal QMS requirements.
• Collaborate with Quality and address nonconformances, CAPAs, and risk management.
• Support internal and external audits with engineering documentation and evidence.

• Specify, procure, install, and maintain production equipment.
• Develop preventive maintenance schedules and ensure equipment readiness including safety requirements.
• Coordinate PM activities with vendors and providers.
• Manage equipment calibration needs in coordination with Quality.

• Work closely with R&D to transition new products into manufacturing.
• Partner with Supply Chain on vendor qualification and component manufacturability.
• Support Operations in production planning and capacity scaling.

• Lead engineering projects from concept through implementation.
• Manage timelines, budgets, and resource allocation to achieve business objectives.
• Communicate project status to leadership and stakeholders.

• Owns facility maintenance.
• Leads facility expansion and improvement projects.
• Screens vendor quotes and coordinates vendor repairs on site.
• Works with the landlord and external contractors on problem resolution.

• Builds a positive, high‑performance work culture through leadership, effective communication, talent development, and performance management.
• Change leadership with strong…