Project Manager Internal 4

TekWissen LLC

Pennsylvania Avenue Washington, WA(remote)

JOB DETAILS
SALARY
$71–$78.50
SKILLS
Biomedical Engineering, Biophysics, Clinical Assessment, Clinical Trial, Communication Skills, Cross-Functional, Customer Relations, Diversity, Drug Development, Healthcare, Healthcare Providers, Market Analysis, Market Surveys, Medical Affairs, Medical Equipment, Medical Imaging, Medical Physics, Presentation/Verbal Skills, Product Management, Project/Program Management, Radiation Therapy, Regulations, Risk Management, Surveillance, Technical Writing, Workforce Management, Writing Skills
LOCATION
Pennsylvania Avenue Washington, WA
POSTED
1 day ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan, offering strategic talent solutions to clients worldwide. The opportunity below is with one of our clients, a leading global medical technology company. This organization provides a wide range of diagnostic imaging and laboratory diagnostics, as well as advanced therapies and digital health services. Its solutions span prevention and early detection through diagnosis, treatment, and follow-up care, empowering healthcare providers worldwide.
Job Title: Project Manager Internal
Location: Pennsylvania Avenue, WA 20004
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Remote
Shift: 8:00AM to 4:00PM
Job Description
This is a role well suited for a self-driven professional looking to expand the impact of Medical Affairs work across the organization. As a Clinical Evidence Planning and Evaluations Manager, you will be responsible for:
Creating and driving the Clinical Evidence Strategy for Varian's devices
Creation of Clinical Evaluation Plans, Reports, and Post-Market Clinical Evaluation Plans, and Reports (CEP/CER and PMCFP/PMCFR)
Providing clinical perspective and input to cross-functional teams regarding clinical development, risk management, product management, and post-market surveillance
Execute Post-Market Clinical Follow Up activities (may include customer surveys, annual literature searches, clinical studies)
Provide clinical review of promotional material and claims in support of publishing customer facing content
This position may suit you best if you are familiar with what is below, and would like to develop your skills with Healthineers:

You have familiarity with design and manufacture medical devices, especially those used in the radiation oncology setting
You have exemplary technical writing and verbal communication skills
You prefer an autonomous working environment, as this position is remote.
Required skills and education to have for the success of this role:
Understanding of Clinical Evaluation and Post Market Clinical Follow Up Requirements of class I-III medical devices as designated in the European Union Medical Device Regulation (EU MDR)
Master's or PhD in Medical Physics (preferred), Biophysics, Biomedical Engineering. Other degree programs considered based on experience
2-5 years' experience with clinical evaluations, medical physics, or related field.
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/