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 product development, 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 who has a balance of strategic vision, project execution, and technical rigor.

Responsibilities:

Lead cross-functional projects consisting of R&D, Quality, Regulatory, Manufacturing, and Commercial teams in support of medical product launches from concept to launch
Lead and support execution of technical and cross-functional project work
Provide portfolio management leadership across a number of technical projects to ensure clear communication, proactive identification of risks, and execution excellence. Motivate team members, resolve conflicts, actively problem-solve with teams to remove obstacles to execution
Ensure implementation and rigor of product development processes and design control procedures
Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or enhance current products' ability to address customer needs
Institutionalize new PMO tools, systems, and procedures. mentor and develop team members and share best practices to help improve team effectiveness and efficiency
Guide and facilitate cross-functional projects, collaboratively establish work plans, clarify work commitments, and establish progress update meetings to keep projects on track
Work with Management to develop project strategies and translate them into detailed work plans with budgets and resource allocations.
Continually update project status (time, budget and resource) to reflect progress against plan and report to senior management
Collaborate with stakeholders, functional managers, and cross-functional staff to facilitate seamless project execution
Identify and anticipate project bottlenecks and effectively communicate with Leadership
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
Ensure compliance with quality policies, procedures, and practices
Ensure compliance with all local, state, federal, and safety regulations, policies, and procedures
Other duties may be assigned as deemed necessary by management

Requirements

Bachelor's degree required; concentration in a scientific-related or engineering-related discipline required
A minimum of 6 years of technical project management experience in the medical device or biotechnology industry is REQUIRED.
A minimum of 3 years in product development within the medical device industry is 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 mid-size to 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 is 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
Strong multi-tasking capability with ability to understand project details while keeping an overall "big picture" view of projects, priorities, and strategies is required
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

Cresilon

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Medical Device Research & Development Project Leader