Divisional Project Manager (Ops) jobs in United States
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BeaconMedaes · 2 hours ago

Divisional Project Manager (Ops)

BeaconMedaes is a company focused on innovative solutions in the medical gas solutions sector, and they are seeking a Divisional Project Manager to drive strategic projects and enhance operational performance. The role involves leading project teams, managing timelines and budgets, and ensuring compliance with industry standards while collaborating with various stakeholders.

Health CareManufacturingMedicalMedical DeviceProduct Design
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Growth Opportunities

Responsibilities

Lead planning, design, risk management, and implementation of new production lines on time, within scope, and budget
Manage timelines, budgets, and resources to drive process optimization, automation, and scalability
Coordinate with internal stakeholders and external vendors or contractors
Ensure compliance with standards like FDA CFR Title 21, ISO 13485, Medical Standards, USP Class VI, and cGMP
Establish policies to ensure production quality and compliance with local QMS, TWWDT, and standards
Collaborate with manufacturing sites and experts to define equipment specs, layout, and process flow
Ensure safety, environmental, and regulatory compliance
Work with engineering to integrate automation, quality control, and lean manufacturing
Define final equipment and process specs, manage RFQ and procurement
Support commissioning, validation, and production ramp-up
Lead cross-functional teams
Report project status, risks, and milestones to leadership
Facilitate training and knowledge transfer for production and lab staff

Qualification

Medical Gas ExperienceProject ManagementLeadership of Cross-Functional TeamsPolicySOP DevelopmentISOGMP KnowledgeLean ManufacturingOffice365 ToolsCADSimulation SoftwareSix Sigma ExperienceCommunicationProblem-Solving

Required

policy and SOP development
experience in medical gas, filtration, fluid handling, or related fields preferred
leading manufacturing line setup
supporting product development labs
working with regulated products and ISO cleanrooms
strong manufacturing, automation, and lab knowledge
proven leadership of cross-functional teams
excellent communication and problem-solving
project management with Office365 tools
Bachelor's in Engineering or related field
7+ years in project management or process engineering
International travel required to sites in Denmark, UK, India, Canada, and China

Preferred

Master's
PMP certification
CAD and simulation software
ISO and GMP knowledge
lean manufacturing and Six Sigma experience

Company

BeaconMedaes

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BeaconMedæs specializes in the design, education, supply, and installation of piped medical gas distribution systems.