Medical Device R&D Project Leader

Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.

Job Description

The Medical Device R&D Project Leader will be responsible for facilitating the successful execution of the company’s projects from concept through launch and product/process stabilization. They will plan and lead 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 to deliver every project on time, within budget, and scope. This is a hands-on role for a strong technical leader with who has a balance of strategic vision, project execution and technical rigor.

Responsibilities:

• Work with cross-functional teams to plan and manage high-priority projects.
• Keep both project team members, and management fully apprised of project initiative status and issues.
• Ensuring project information (such as scope, goals, resource analyses) are properly documented and archived for portfolio.
• Develop strong positive relationships with peer groups and external partners, to be able to share, teach, and institutionalize new PMO tools, systems, and procedures.
• Share best practices to help improve team effectiveness and efficiency.
• Analyze portfolio data to create reports and dashboards.
• Other duties may be assigned as deemed necessary by management.

• Guide and facilitate cross-functional project, collaboratively establish work plans, clarifying work commitments, and establishing progress updates meetings to keep projects on track.
• Manage cross-functional project teams – Motivate team members, resolve conflicts, actively problem solve with teams to remove obstacles to execution.
• Work with Management to develop project strategies and translate them into detailed work plans with budgets and resource allocations.
• Collaborate with stakeholders, functional managers, and cross-functional staff to facilitate seamless project execution

• Continually update project status (time, budget and resource) to reflect progress against plan and report to senior management.
• Identify and anticipate project bottlenecks and effectively communicate with Leadership
• Facilitate the efficient use of resources and align personal and project goals with company goals.
• 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.

Requirements

• Bachelor’s degree required; concentration in a scientific-related or engineering-related discipline strongly preferred.
• A minimum of 6 years of technical project management experience in the medical device or biotechnology industry 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 are REQUIRED.
• Self-motivated with the ability to plan and manage time across multiple priorities, with a demonstrated strength in time management and execution, is required.
• Proven track record managing project teams with indirect authority required.
• Excellent problem-solving, conflict resolution, and analytical skills are required.
• Demonstrated experience in Project Management and Product Lifecycle Management practices for large-scale projects preferred.
• Direct experience in new product development through the launch of medical devices is strongly preferred. Direct experience with design control processes and Class II/III products strongly preferred.
• Experience managing projects using Microsoft Project and any other work-stream management tools required. Strong working knowledge of Microsoft Office is required.
• Excellent communication (written and verbal) communication, presentation, and critical thinking skills required.
• Requires strong leadership and organizational skills including attention to detail and multi-tasking skills.
• Able to understand project details, but keep an overall “big picture” view of projects, priorities, and strategies.
• Project Management Training and/or Project Management Professional (PMP) Certification is strongly preferred.
• Formal training and experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is 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.

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Benefits

• Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications.
• Paid Vacation, Sick, & Holidays
• Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
• Monthly MetroCard Reimbursement
• 401(k) & Roth Retirement Savings Plan with company match up to 5%
• Work/Life Employee Assistance Program
• Company Paid Life and Short-Term Disability Coverage