Project Manager - SR

Company: CTG
Location: Augusta
Posted on: September 25, 2022

Job Description:

Project Manager - SRUnited StatesNewInformation TechnologySep 09, 2022Post Date22202242Requisition #Apply for JobShare this JobSign Up for Job AlertsCTG is seeking to fill aSr. Project Manageropening in Rochester, MN.Location: Rochester, MNDuration: 6 monthsWe are seeking a Senior Project Manager to help our client lead projects in the Software as Medical Device (SaMD) & Regulatory group within their Center for Digital Health.Duties:Leads projects of very large size and/or high complexity, and/or multiple projects of mixed complexity levels and sizes. May provide support to one or more projects of high complexity as part of a program or portfolio team. Manages project with budget responsibility up to (USD) 5 million, and may require matrix supervision of staff from other IT departments and divisions, and contractor/vendor resources. Responsible for achieving project objectives and completion on time, on budget, and in conformance to Clinic enterprise, departmental, and IT methodologies and practices as required. Solicits technological input from senior technical resources assigned to their project team(s), and facilitates technology problem-solving activities. Works directly with institutional committees and oversight bodies to understand priorities, develop project action plans, facilitate approvals, and work across organizational boundaries to develop and/or implement project proposals that meet the objectives of those groups. Supports strategic planning and execution of multi-year initiatives that may involve multiple inter-relationships and complexities, requiring the development and execution of complex communication and management plans to achieve. Makes judgments and takes any reasonable action required to accomplish agreed to project objectives under general guidance. Serves as subject matter expert regarding both departmental and institutional project management practices, methods and standards. Leads the ongoing adoption and continued evolution of a Project Focused Culture within the Information Technology department. Manages multiple competing objectives and communicates complex technical information in clear and unambiguous terms to management and end user personnel. Strictly adheres to budget management and guidelines of both the Information Technology department and the institution. Performs additional job-related functions as detailed by immediate supervisor.Skills and Experience:Required Skills:

• 5+ years of experience of demonstrated project / technical program management / systems engineering experience with complex medical device R&D.
• Complete understanding and experience with regulated product development life cycle from concept to launch.
• Working knowledge of FDA Quality regulations related to medical device development and quality and regulatory standards 21 CFR 820, ISO 13485, 14971, 62304, 62366.
• Understanding of medical device DHF, DMR, and medical device regulatory submission deliverables.
• Identify stakeholders, understand needs of the customer, and facilitate early identification of potential safety risks for a variety of AI/ML software as medical device products.
• Experience educating and guiding novice teams through the regulated medical development lifecycle.
• Well-versed in cross-functional communications through development activities (Planning, Design Inputs/Outputs, Design Verification/Validation, Design Transfer).Education:Minimum education and/or experience:
  • Bachelors Degree and a minimum of 10 years experience managing projects ranging from simple to difficult complexity while demonstrating increasing scope and depth of responsibilities, and involving multiple technological environments and/or business areas that IT supports, with demonstrated competency in the application of PMI Process Groups and Knowledge Areas OR
  • Masters Degree with a minimum of 7 years experience managing projects involving Information Technology and/or Healthcare disciplines, ranging from simple to difficult complexity while demonstrating increasing scope and depth of responsibilities, and involving multiple technological environments and/or business areas that IT supports, with demonstrated competency in the application of the PMI Process Groups and Knowledge Areas.Licensure/Certification Required:
    • Possession of current Project Management Professional (PMP) certification, or a comparable current certification from a nationally-recognized project management governance body. This certification must be obtained within three (3) years of date of hire.To Apply:To be considered, please apply directly to this requisition using the link provided.CTG's Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.CTG is a leading provider of digital transformation solutions and services that accelerate clients' project momentum and achievement of their desired IT and business outcomes. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG has operations in North America, South America, Western Europe, and India. For more information, visit www.ctg.com.Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people are the culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work-certified company across many of our global operations.CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.CTG is an Equal Opportunity and Affirmative Action Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. Our Affirmative Action program serves to promote occupational equality and diversity through good faith efforts. CTG is fully committed to promoting employment opportunities for members of protected classes.Additional Information
      • Job Function: Project Management & Administration
      • Education Level: Bachelor's Degree (16 years)
      • Work Remote: Yes
      • Travel: No

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