Medical Device R&D Project Leader/Manager

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:

• Http://www.bloomberg.com/video/vetigel-the-band-aid-of-the-future-stops-bleeding-instantly-PaIvLxjcS66F5IWO1SsKtA.html
• Http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en

The Medical Device R&D Project Leader/Manager will be responsible for facilitating the successful execution of the company’s projects from concept through launch and product/process stabilization. They will plan projects in alignment with the goals of the company and manage cross functional teams to accomplish those goals. They will partner with stakeholders across the company to align expectations, communicate progress, and ensure project success. They will take on the management of key projects with the goal of delivering every project on time, within budget, and within scope.
Responsibilities:

• Utilize available tools and standard methodologies to manage projects to ensure successful execution (e.g. MS Project, web-based dashboards) and structures (e.g. reports and meetings) and communication across R&D and other stakeholders.
• Work with Management to develop project strategies and translate them into detailed work plans with budgets and resource allocations.
• Keep both project team members, and management fully apprised of project initiative status and issues.
• Collaborate with stakeholders, functional managers, and cross-functional staff to facilitate seamless project execution
• Manage cross-functional project teams – Motivate team members, resolve conflicts, actively problem solve with teams to remove obstacles to execution.
• Continually update project status (time, budget and resource) to reflect progress against plan and report to senior management.
• Analyze portfolio data to create reports and dashboards.
• Share best practices to help improve team effectiveness and efficiency.
• Guide and facilitate cross-functional project, collaboratively establish work plans, clarifying work commitments, and establishing progress updates meetings to keep projects on track.
• Develop strong positive relationships with peer groups and external partners, to be able to share, teach, and institutionalize new PMO tools, systems, and procedures.
• Identify and anticipate project bottlenecks and effectively communicate with Leadership
• Ensuring project information (such as scope, goals, resource analyses) are properly documented and archived for portfolio.
• Work with cross functional team to plan and manage high priority projects.
• Other duties may be assigned as deemed necessary by management.
• Facilitate the efficient use of resources and align personal and project goals with company goals.

Requirements

• A minimum of 6 years of technical project management experience in medical device or biotechnology industry is REQUIRED.
• Project Management Training and/or Project Management Professional (PMP) Certification is strongly preferred.
• Excellent communication (written and verbal) communication, presentation and critical thinking skills required.
• Legal authorization to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future is required.
• Excellent problem solving, conflict resolution, and analytical skills is required.
• Requires strong leadership and organizational skills including attention to detail and multi-tasking skills.
• Bachelor’s degree required; concentration in a scientific-related or engineering-related discipline strongly.
• Experience managing projects using Microsoft Project and any other work management tools required. Strong working knowledge of Microsoft Office is required.
• Formal training and experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is required.
• A minimum of 6 years in one or more of the following functional areas preferred: engineering, research and development, planning, and/or operational function is REQUIRED.
• Self-motivated with ability to plan and manage time across multiple priorities, with a demonstrated strength in time management and execution, is required.
• Able to understand project details, but keep overall “big picture” view of projects, priorities, and strategies.
• Direct experience in new product development through launch for medical device is strongly preferred.
• Proven track record managing project teams with indirect authority required.
• Demonstrated experience in Project Management and Product Lifecycle Management practices for large scale projects preferred.

Benefits

• Paid Vacation and Holidays
• Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications.
• 401(k) Retirement Savings Plan
• Firm Paid Life and Short-Term Disability Coverage
• Medical, Dental, and Vision Insurance