Operations Engineering Manager
Core
Oversee daily operations of a plastic injection molding facility producing medical device components, ensuring safety, quality, delivery, and cost goals while driving continuous improvement.
Role type
Senior Operations Manager (Manufacturing)
Builds
Medical device components via plastic injection molding
Domain
Medical device manufacturing / Plastic injection molding
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing leadership, Plastic injection molding expertise, Regulatory compliance (ISO 13485, FDA), Lean Manufacturing, Six Sigma, Strategic planning, Resource allocation, Team management, DFM collaboration, KPI monitoring, Preventive maintenance coordination, Supply chain collaboration
Preferred skills
Six Sigma Green Belt or higher, PMP, Lean certification, Class I/II/III medical device manufacturing experience, Scientific injection molding process knowledge, Mold and tool maintenance knowledge
Technologies
Office software (word processing, spreadsheets, presentations, databases)
Responsibilities
Oversee daily operations of injection molding production to meet safety, quality, delivery, and cost goals; Ensure compliance with regulatory and quality system requirements (ISO 13485, FDA cGMP); Develop and implement operational policies, procedures, and best practices; Collaborate with management and commercial teams to evaluate manufacturing feasibility for quote compilation; Forecast operating costs and direct preparation of budget requests; Partner in developing strategic plan and Annual Operating Plan (AOP); Review and establish material, equipment, and manpower resource requirements; Prioritize production schedules based on product introduction, equipment efficiency, and materials supply; Select and develop personnel to ensure efficient operation; Account for controlling manufacturing operation to meet quality and cost targets; Plan, organize, and lead production ramps to meet customer demand; Drive continuous improvement initiatives using Lean, 5S, and KAIZEN; Collaborate with Engineering on design for manufacturability (DFM), mold validation, and new product introduction (NPI); Monitor KPIs to identify areas for improvement in efficiency, scrap reduction, and downtime; Oversee plant scheduling, capacity planning, and resource allocation; Ensure proper preventive maintenance and readiness of molding equipment and tooling; Coordinate with supply chain and procurement teams for material availability and inventory optimization
Seniority
Senior, hands-on IC with strategic planning responsibilities