Project Manager, Program ​/ Project Manager, Operations Manager

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At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

This Engineering Project Manager is responsible for the overall direction, coordination, implementation, execution, control and completion of multiple medical device new product/service development projects that include the following: new products, line extensions and product improvements (which also includes business continuity and product support projects) ensuring consistency with company strategy, commitments and goals.
This person will also be responsible for managing complex new product development projects with multi-functional teams; responsibilities include the planning of all project activities according to defined product development and stage gate processes, coordination of project team activities to meet project deliverables, FDA/ISO requirements, and the management of the overall project schedule, resource requirements, risk assessment, business case, and budget, including progress reporting and reviews with senior management.

• Work with Product Managers, Sales Team, Product Specialists, Manufacturing and Engineers in creating design and manufacturability process validation plans and lab tests. Attends CFT market research sessions when appropriate.
• Leads and drives the planning and implementation of multiple repair/NPD projects, varying in size and scope and recommends revisions in project work plans as appropriate to meet changing needs and requirements.
• Assembles Cross Functional Teams (CFT) and leads them through the development process for projects of varying complexity, including new medical devices and services.
• Identifies and defines resource requirements needed and recommends assignments for individual CFT member responsibilities.
• Facilitates the definition of projects’ scope, goals and deliverables.
• Manages day-to-day operational aspects of projects and scopes.
• Leads Voice of Customer initiatives and works closely with Product Management to define customer/market requirements for new products development
• Works with supervisor in managing project resource allocations across all projects.
• Works with various department heads to assure alignment of CFT member objectives and work schedules to assure projects deliverables are achieved.
• Effectively applies Stage/Gate methodology and enforce project standards to drive project completion.
• Leads and manages creation of Gate deliverables and Gate presentations with project team and senior management.
• Ensures project documents and Gate deliverables are complete, up-to-date, and stored appropriately.
• Assists in identifying project risks and critical issues and developing applicable mitigation plans to minimize exposure on projects.
• Suggests areas for improvement in internal processes along with possible solutions.
• Prepares and presents reports defining project progress, problems and solutions for management, as needed.
• Implements and manages project changes and interventions to achieve project outputs.
• Complies with and helps to enforce standard New Product Development policies and procedures.
• Work with CFTs to develop project schedules and tracks project deliverables to completion
• Leads and coordinates market release inventory requirements with Supply Chain and Materials/Logistics departments.
• Work with Quality, Regulatory, and Document Control to ensure all project documentation requirements are fulfilled for product release.
• Provides input and leads design/documentation review meetings.
• Develops and manages budgets for the project including resource loading, external expenses and capital requirements.
• Actively seeks collaboration and builds relationships with internal customers and external partners to improve overall outcomes and timely project completion.

• Bachelor’s degree with 5+ year’s successful demonstrated experience managing complex new product development projects is required.
• Technical degree in the sciences or engineering fields highly beneficial.
• Project Management Professional (PMP) or New Product Development Professional (NPDP) certification(s) a plus.
• Demonstrated planning and organizational skills with background and experience in Design Control and Stage Gate methods is required.
• Experience with FDA guidance, ISO 13485 regulations and CE Mark requirements is highly preferred. Experience with Medical Device development is highly desired.
• Must be a proficient user of Microsoft Project (or similar), Excel, Power Point, Visio, and Word.
• Possess ability to conduct market research via internet.
• Up to 15% domestic travel is required.

• Project Management
• Coaching
• Communication Competency
• General Business Acumen
• Extremely Analytical
• Strong Problem Solving and Critical Thinking
• Decision Making
• Well Developed…