Project Manager

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Grant on 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. is a leading manufacturer of molecular and immunological reagents designed for diagnostic applications. The company specializes in providing innovative solutions to enhance point-of-care diagnostics and streamline assay development for various medical conditions, including infectious diseases and cancers. Meridian is dedicated to advancing medical diagnostics and improving patient outcomes through its high-quality products and services.

📋 Description

• Lead cross-functional new product development projects for in vitro diagnostic (IVD) assays and diagnostic instrument systems in an FDA-regulated medical device environment. • Manage project planning and execution from concept through launch. • Manage design control compliance, schedule, risk, resources, budget, and decision-making. • Partner with R&D, Regulatory Affairs, Quality, Clinical Affairs, Operations, Marketing, Finance, and external development partners to define project scope, goals, and deliverables. • Develop accurate and achievable project plans and timelines and communicate them to team members and leadership. • Drive team ownership and commitment to project plans and recommend changes when necessary. • Track and communicate project performance and analyze completion of short- and long-term goals. • Ensure on-time completion of project tasks according to project and company procedures. • Facilitate cross-functional project team meetings. • Perform other duties as assigned.

🎯 Requirements

• Bachelor’s degree in science, engineering or business administration or related field required; advanced degree preferred. • At least 5 years of project management experience leading cross-functional product development projects. • Direct experience managing FDA-regulated medical device product development projects. • Working knowledge of medical device design control requirements and product development processes, including design planning, design reviews, and risk management. • Experience with in vitro diagnostic (IVD) products, including assay and/or diagnostic instrument development preferred. • Experience working within Quality Management Systems compliant with FDA 21 CFR Part 820 and applicable medical device regulations preferred. • Project management qualification (PMP) or equivalent preferred. • Demonstrated project management skills with proven practical project management experience, preferably in the diagnostic or related biotechnical field. • Demonstrated successful management of products from concept to launch. • Ability to perform critical path identification. • Excellent problem-solving skills; self-starter, detail-oriented, able to prioritize and balance workloads and timelines, and manage multiple projects simultaneously. • Ability to work independently and collaboratively with peers and colleagues in a cross-functional setting. • Well organized, able to meet strict deadlines and perform under pressure in a fast-paced work environment. • Excellent interpersonal, organizational, written, and oral communication skills. • Basic understanding of device development, engineering, and manufacturing activities is a plus.

🏖️ Benefits

• Remote work option • 20% travel as required to support project teams and key milestones