Project Manager

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.

Position Summary

Directs all phases of medical device program and project development from cross-functional team inception, completion of a commercialized product, launch, post-market surveillance and change control.  Organizes and leads cross-functional teams on multiple medical device new product development and change control projects at varying complexity that may include the following:  acquisitions; major new products; major and small line extensions; major redesigns; sourcing projects; inter-divisional projects; and value improvement and business continuity projects.  The programs and projects managed by the Project Manager represent critical strategic imperatives and are global in both scale and scope, and have direct visibility to Senior Management.  The recommendations from the Project Manager and cross-functional teams have impact on the division affecting the financial, employee and customer view of the company.  This role reports to the Senior New Product Development Portfolio Manager or Senior Project Manager in the Project Commercialization Department.  

Duties

• Develops and drives the cross-functional plan/strategy as well as execution of new products and change control projects directed by the Portfolio Management Team.
• May provide key program or project support with the integration of acquisitions. 
• Provides leadership, mentoring and technical expertise to ensure high quality products for the market place are delivered right the first time.
• Ensures the New Product Development and Change Control Project process is followed.  Owns the overall program and project management of the product development to ensure targets are met for performance, features, quality, costs, reliability, manufacturability, etc.
• Creates, monitors and updates project plans.
• Acts as the primary leader for assigned program and project activities, leading review sessions to discuss project status, critical paths, risks and milestones.
• Establishes milestones and monitors adherence to master plans and schedules.  Identifies program or project problems and obtains solutions such as allocation of resources or changing specifications.
• Directs the work of the assigned cross–functional team members involved in product definition, design, development, production, regulatory, quality, marketing, and clinical applications.
• Facilitates communication and interaction among functional business heads to ensure transparency of critical deliverables and milestones in the New Product Development and Change Control Project process.
• Delivers critical, timely communications to the Sr. Leadership Group on product development and delivery.
• Ensures smooth transition across the organization for initial concept through product development, manufacturing, design limited market release, product launch and change control.
• Identifies critical dependences, risks and contingency plans.  Proactively monitors progress, anticipating the effect of dependencies on schedule, cost, etc.
• Participates in identifying and implementing improvements and updates to the New Product Development and Change Control Project process, including adding deliverables, tools and/or processes to address functional and product requirements.
• Provides performance feedback regarding cross-functional team members to appropriate Functional Managers.
• May participate on the Portfolio Management Team ensuring the New Product Development pipeline is continually filled with the right programs and projects along with the right Change Control projects.

Required Experience

• Bachelor’s degree, preferably in a Science or Marketing discipline; Master’s degree is a plus
• 7+ years’ experience, 4+ in program, project or portfolio management associated with product development and change control in a medical device or a regulated industry 
• Experience in more than one of the following disciplines a plus:  Design and/or Development Engineering, Product Marketing, Finance, Manufacturing, Regulatory, Quality
• Strong project management skills required; PMP certification a plus
• Experience leading projects from initial concept, through development, 510(k) submission and verification/validation testing, into Manufacturing through product launch and change control.  Ability to balance Customer needs; manufacturing, business and regulatory requirements to expedite launch of the right new product development products and change control projects to market.
• Experience successfully managing programs and projects through medical device New Product Development and Change Control Project process.   Track record of man