Manufacturing Program Manager

2 weeks ago

Southington, Ohio, United States ICU Medical Full time

Position Overview

The Manufacturing Program Manager is entrusted with the comprehensive oversight of programs and initiatives from inception to deployment, focusing on new features and life cycle management. This role is pivotal in ensuring that project teams, comprising both technical and non-technical subject matter experts, adhere to the established business objectives and technical strategies. The Program Manager is responsible for articulating challenges, proposing solutions, and providing updates regarding their programs. This individual possesses the necessary skills to cultivate high-performing, cross-functional teams that ensure timely and quality execution of assigned programs. Collaboration with external partners is essential to align and drive shared goals and initiatives within the organization. The Program Manager proactively identifies potential obstacles, risks, and issues that may hinder the successful realization of business and program goals.

Key Responsibilities

Develops analyses of timelines, resources, and budget data to facilitate scenario planning, risk evaluation, and informed decision-making. Monitors and evaluates team performance metrics (time, cost, and quality milestones) against the approved project plan. Collects, analyzes, integrates, and maintains cross-functional deliverables, including Integrated Project Plans. Directs daily Project Team activities to achieve project milestones and ensure compliance with corporate policies and procedures, anticipating potential bottlenecks. Creates and implements a communication strategy to guarantee effective and timely exchanges between the Core Team, functional management, senior management, and external partners. Organizes and leads productive meetings, assigning action items, tracking their resolution, updating project plans, and addressing issues as necessary. Prepares regular program status reports as required by management. Supports Quality System & Compliance: Ensures readiness for inspections and manages CAPA-related activities, including necessary training. Engages in special projects as they arise.

Required Knowledge & Skills

Ability to synthesize available data and provide actionable insights to facilitate team progress. Proven expertise in leading and managing cross-functional teams to achieve objectives in a complex, matrixed environment. Fundamental understanding of functions related to specific program assignments is essential, along with demonstrated leadership competencies such as diligence, planning, analysis, and communication. Strong written and verbal communication skills, including advanced technical writing and risk mitigation strategy development. Cross-functional experience in areas such as Development, Quality, Medical, Commercial, Manufacturing Operations, Clinical, or Regulatory is advantageous. Proficiency with Microsoft Office tools: Outlook, Teams, Word, Excel, PowerPoint, and Project. Experience with FDA medical device design controls is a plus. Familiarity with Medical Device and FDA standards is beneficial. Knowledge of Oracle E-Business suite for PR/PO creation and service/goods receipt is a plus. Familiarity with tools such as Agile PLM, JIRA, and Code Collaborator is advantageous. Systems engineering experience, particularly in defining and releasing Stakeholder Needs, User Needs, System Requirements, and Subsystem Requirements for medical devices, is a plus. Human Factors experience, including training preparation and user study coordination, is beneficial. Informal testing/assessment skills, particularly in early testing of software and product prototypes, are advantageous.

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 institution is required; a Master's degree is preferred.

· 7+ years of experience in a program/project management capacity, preferably within the Medical Device industry, with a focus on product development processes.

· PMP Certification is strongly preferred.

Work Environment

· This role is primarily sedentary.

· Operates in a professional office environment utilizing standard office equipment.

· Typically requires minimal travel.

Salary Range: $116,000-$155,875

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary based on various factors, including relevant experience, skills, education, and certifications.

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