Position Summary// The Program Manager has overall accountability for programs and projects from concept through launch for new feature and/or life cycle management. The Program Manager is responsible to ensure project teams consisting of technical and non-technical SMEs are on track to the established and approved business plan and technical strategies. The PM is responsible for presenting issues, recommendations and updates in regards to their programs. The PM has the required skills to form high performing cross-functional / cross-company teams that will result in the timely and high quality execution of the assigned program(s). The PM works with Pharmacy Systems R&D’s external partners with the role to influence and drive collective goals and initiatives of the business. This individual looks for key predictive indicators of potential roadblocks, risks, and issues which could impede successful achievement of the business and program objectives. This individual is capable of identifying and communicating key project and program risks, working with the technical teams to establish risk mitigation activities, and integrating results into consistent program communications. * * Essential Duties & Responsibilities * Generates analyses of timeline (schedule), resource, and budget information that facilitates scenario & contingency planning, risk assessment and decision-making * Monitors and tracks team performance metrics (time, cost and quality milestones) relative to the approved project plan. * Collects, analyzes, integrates, and maintains cross-functional deliverables (i.e. Integrated Project Plans). * Drives day-to-day Project Team activities to meet project milestones and keep functions on track in compliance with Corporate and Site policies and procedures. Understands critical path activities and anticipates steps that may be bottlenecks. * Develops and executes communication plan to ensure effective and timely communication between the Core Team and functional management, senior management, and external partners. * Organizes and facilitates effective meetings. Identifies and delegates action items, follow-up/track action items to resolution, updates project plans & deliverables, as required, identifies issues and ultimately resolves issues off-line (to ensure effective meetings at all levels), with subsequent escalation as required. * Prepares periodic program status reports as requested by management * Quality System & Compliance Support: Inspection readiness and CAPA-related activities; including training if required * Work on special projects as they arise * * Knowledge & Skills * Ability to synthesize known data and provide answers/direction to allow the team to take action * Well demonstrated expertise in leading and managing cross-functional teams to achieve objectives in a highly matrixed environment. * Basic knowledge of functions as related to their particular program assignments is essential. The incumbent should also have demonstrated successful leadership competencies (diligence, planning, analysis, and communication). * Must have strong written and verbal communication skills (including presentation skills), advanced technical writing capability, and expertise in development of risk mitigation strategies. * Cross-functional experience in different areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical or Regulatory is preferred but not required. * Familiarity with Microsoft suite of tools: Outlook, Teams, Word, Excel, Powerpoint, Project · Experience with FDA medical device design controls is a plus. * Familiarity with Medical Device and FDA standards is a plus * Familiar with Oracle E-Business suite for the creation of PR/PO, and receiving after services/goods are delivered is a plus * Familiarity with the following tools: Agile PLM, JIRA, Code Collaborator is a plus * Systems engineering experience; specifically assisting in the definition and release of Stakeholder Needs, User Needs, System Requirements, and Subsystem Requirements for a medical device is a plus * Human Factors experience; specifically preparing and delivering training for user study participants, coordinating user study activities and logistics with internal and external teams is a plus * Informal testing/assessment skills; involved in internal and early testing of software and product prototypes to facilitate early identification of product issues is a plus Minimum Qualifications, Education & Experience · Must be at least 18 years of age · Bachelor’s degree in Engineering, Biological Sciences, Business or related fields from an accredited college or university is required, Masters degree preferred · 7 years of experience required in a program/project management related capacity, preferably in the Medical Device industry with product development process experience · PMP Certification strongly preferred Work Environment · This is largely a sedentary role. · This job operates in a professional office environment and routinely uses standard office equipment. · Typically requires travel less than 5% of the time* Salary Range: $116,000-$155,875 o The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: *Program Manager - R&D Location: CA-San Diego Requisition ID: 24300634