R&D Medical Device Project Manager
R&D Medical Device Project Manager
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Salary Not Disclosed
1 Vacancy
Job Description
Cresilon is a Brooklyn-based biotechnology company that develops manufactures and markets hemostatic medical devices utilizing the companys proprietary hydrogel technology. The companys plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The companys current and future product lines target veterinary human trauma and human surgical applications. Cresilons mission is to save lives. Learn more about the company at .
Job Description
The R&D Medical Device Project Manager will facilitate the successful execution of Cresilons projects from concept through product development launch and product/process stabilization. They will plan lead and contribute to projects in alignment with the companys goals 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 manage key projects to deliver every project on time within budget and scope. This is a hands-on role for a strong technical leader who balances 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 the execution of technical and cross-functional project work.
- Provide portfolio management leadership across several technical projects to ensure clear communication proactive identification of risks and execution excellence. Motivate team members resolve conflicts and 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
- Bachelors 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 devices and their regulatory clearance 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 $100000 - $160000 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
Required Experience:
IC
Employment Type
Contract
