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. Essential Job Functions Manufacturing Engineering Leadership 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. Process Development & Optimization 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. Production Support 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. Quality & Regulatory Compliance 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. Equipment & Tooling Management 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. Cross‑Functional Collaboration 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. Project Management Lead engineering projects from concept through implementation. Manage timelines, budgets, and resource allocation to achieve business objectives. Communicate project status to leadership and stakeholders. Facilities 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. Talent Builds a positive, high‑performance work culture through leadership, effective communication, talent development, and performance management. Change leadership with strong followership. Develops capital plans, appropriation requests and related reporting. Implements year‑on‑year improvement strategies to increase OTD, productivity, safety/quality improvements, and cost savings. Safety Serves as the Company Safety Officer. Ensures OSHA and other regulatory compliance. Owns incident reporting, investigation, training and compliance. Coordinates internal and external safety audits and ensures follow‑up on actions. Manages the Safety Committee Team and resolves safety issues quickly. Manages hazardous materials waste and wastewater discharge process. Qualifications Bachelor’s degree in engineering (mechanical, electrical, biomedical, or related field). 7+ years of engineering experience, including 2+ years in a leadership or team‑lead role. Proven experience with project management. Proven experience with automation related projects. Injection molding/Extrusion experience a strong plus. Excellent communication, prioritization, and cross‑functional collaboration skills. Proven track record of results. Strong leadership, communication, and interpersonal skills. High EQ. Strong project management and organizational skills. Strong analytical skills, capable of resolving complex problems. Lean six‑sigma certification preferred. Experience utilizing AI to improve productivity a plus. MSOffice, Asana, ERP, other software relevant to the job. Strong problem‑solving and analytical skills. Ability to balance strategic thinking with hands‑on execution. Excellent communication and documentation abilities. Adaptability and comfort working in a resource‑constrained environment. Collaborative mindset with a willingness to jump in wherever needed. Hands‑on experience with process validation, equipment qualification, and documentation. Demonstrated ability to work effectively in a small company or startup environment. Direct Reports Direct reports include engineers, technicians, and machine shop. Why Join Us? You’ll have the opportunity to make a direct and meaningful impact on manufacturing performance, product quality, and process innovation within a quality driven, compliance focused manufacturing environment where precision and reliability are critical. In this role, your contributions extend beyond operational efficiency, helping ensure that life enhancing and potentially lifesaving products are produced safely, consistently, and at the highest standard, while collaborating with cross functional teams to drive continuous improvement, optimize processes, and deliver outcomes that directly support patient health and well‑being. #J-18808-Ljbffr Salaera