Project Manager (Device)

Job Description Our client is a mobility solutions provider with a solution that integrates evidence-based best practices in high-risk Hospital Acquired Pressure Injury (HAPI), patient falls and Safe Patient Handling and Mobility (SPHM) activities. About the Role This position will drive the product life cycle with quality and regulatory compliance needs across the enterprise. Duties and Responsibilities Lead lean manufacturing project for production and inventory control system implementation. Risk assessment of production and development projects (Design and Process FMEAS, Product Risk Assessments, Quality Plans, Risk Management Plans/Reports) v2. Act as Management Representative ensuring compliance with essential domestic and international regulation requirements and/or programs such as FDA's Quality system Regulation and ISO standards. Partner closely with technical and regulatory leaders in ensuring that product requirements, usability and other key components of the regulated Design History File (DHF) are appropriately captured and updated per Company’s Standard Operating Procedures (SOPs). Represent this expertise to relevant regulatory bodies during any product audits. Drive development of product positioning, impactful messaging that resonates with both customers and sales teams, field assets to enable conversions, conference presence and planning to maximize exposure, Public Relations and Investor Relations initiatives. Guide all stages of the Software and hardware development lifecycle by serving as the Product/Portfolio Leader; drive successful trade-offs affecting cost, time to market, user functionality and adoption. Be recognized in the organization as the Subject Matter Expert in their solution space. Build effective relationships with contract manufacturers to meet delivery and budgetary goals. Lead service/product line in existing and into new market opportunities. Write and present marketing plans for product launches. Understand competitive products, strategies and their marketing, and track sales data and analyze trends for use by sales, marketing manufacturing planning. Job Requirements 3+ years in a Product Management or Product Marketing role. 5+ years of experience and progression in the MedTech, or medical device field. Demonstrated experience in conceiving, developing and launching regulated digital and/or connected products on a global scale. Self-starter with a strong drive that can work independently and apply sound judgment to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction. Ability to influence decision-making and action across the organization (R&D, Program Management, Operations, Clinical, Education, Supplier Management). Knowledge in GCP & FDA regulations and guidelines for medical devices. Experience in supply chain and supplier management within medical device. Experience leading service/product line in existing and into new market opportunities is a plus. Experience writing and presenting marketing plans for product launches is a plus v2. Understanding of competitive products, strategies and their marketing, and track sales data and analyze trends for use by sales, marketing manufacturing planning is a plus. Excellent interpersonal skills and ability to work well with all levels of engineers/staff. Ability to work under pressure and be flexible on the schedule. Ability to travel to designated locations as needed. Ability to sit at a workstation operating a device for at least 8 hours per day and lift 20 lbs. #J-18808-Ljbffr Denttach LLC