Biomedical Engineer (Remote, US)

International Consulting Associates, Inc.

Mandaluyong

23h ago

About ICA Global

International Consulting Associates, Inc. is a rapidly growing company, located in the D.C. / Metro area. We were founded in 2009 to assist firms with evaluating and achieving their objectives.

We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects.

Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again! We offer a range of management solutions and technical services on domestic and international programs.

We are results focused and have a proven track record supporting federal agencies and large government services primes in three main areas : Research and Data Analysis, Advanced Data Science, and Strategic Services.

And if that isn't amazing enough, ICA has established itself as a critical partner of the US Food and Drug Administration (FDA).

We currently support multiple analytics and research programs with offices including the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM).

We believe in our people! We support our high performing team and encourage work / life balance. We strive to create and foster an environment of collaboration - one team.

We care about our mission and delivering value that makes a real-world impact. We are committed to hiring and developing diverse, dynamic and highly skilled teams into an atmosphere that is safe and inclusive.

We are passionate about creating solutions that leverage technology, data science, and machine learning to help make our world a better place!

About the Biomedical Engineer

As a biomedical engineer you are a professional problem-solver who looks for ways to apply technological solutions to medical challenges.

Specifically, you are mission driven with a passion to leverage real world evidence to advance medical device innovation and patient safety.

You are an individual that is creative in your thinking and scientifically innovative in nature. You are inquisitive and team oriented.

Responsibilities and Duties (include but not limited to) :

Work as a biomedical engineering team member on cross-functional teams throughout the development process

Review a selection of internal FDA records, identify those records that contain Real World Evidence (RWE), and collect data around the use of RWE to support regulatory decision-making.

Perform a detailed analysis on internal records containing RWE and, for each record :

Identify issues raised by the subject matter experts for RWE-containing internal records related to RWE use (e.g., data quality, study execution, etc.), and

Identify how items raised by SME teams are conveyed to the stakeholders and addressed during a review.

Compile data and create a repository of relevant RWE :

Utilize RWE to at least in part support the marketing authorization

Summarize what RWE was used in these records and how the RWE support the marketing submission

Did not utilize RWE for marketing authorization

Assist with review of SOPs, RWE review protocols, RWE standards development as needed

Responsible for adhering to SOPs and documenting all review work

Support risk analysis activities

Conduct research and product reports as required

Requirements :

0-3 years of experience with a bachelor's degree in Biomedical engineering, or similar discipline

Impeccable attention to detail, strong organizational skills, and ability to multi-task under pressure

Excellent written and communication skills

Ability to obtain, and maintain, and Public Trust Clearance

Preferred Qualifications and Core Competencies :

Current HHS Public Trust

Prior, successful experience working in a remote environment

Previous, experience supporting FDA, or other HHS Agencies

Experience working on federal government contracts

Clearance :

Applicants selected will be subject to a security investigation and may need to meet eligibility requirements for access to classified information;

Public Trust clearance is required.

Vaccine Status :

ICA Global is a federal contractor working directly with the U.S. Government and federal agencies. Vaccination for the coronavirus disease 2019 (COVID-19) is a requirement for employment and applicants selected will need to provide the necessary documentation of their vaccine status.

What we offer :

Competitive salary, work from anywhere

Comprehensive benefits including Health, Dental, Disability and Life

Flexible time off

401(k) plan with match

Location and Telework :

This is a remote position. Candidates may live anywhere in the United States, but must be willing to travel to the office for the occasional team / client meetings.

Flexibility is expected of the employee to be available for client / team meetings, if employee lives outside the Eastern Time Zone.

Occasional travel can be expected. Employee must reside in the continental United States.

Additional Information :

ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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