Skip navigation
Unable to save this job. Please try again later.


Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Columbia, MD 21046
  • 972-299-8459

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest PRINCIPAL BIOMEDICAL ENGINEER jobs in Columbia, MD delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
8 to 15 characters
1 uppercase letter
1 number or symbol
1 lowercase letter
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!


ComTec • Columbia, MD

Posted 2 months ago

Job Snapshot

Travel - Up to 25%
Experience - 7 years
Degree - 4 Year Degree
$70.00 - $110.00/Hour
Biotechnology, Medical Equipment, Manufacturing
Pharmaceutical, Biotech

Job Description


Provide technical leadership on cross-functional teams throughout the development process from concept through commercialization.  Develops design concepts and ideas for new products and product improvements.  Oversees biomedical/mechanical engineering, design, and development work on assigned projects including prototyping and testing and evaluation.  Manages CROs and performs human factors (usability studies), market assessment, or clinical research.  Works with Business Development to explore acquisition or partnership opportunities.  Works with Regulatory to develop strategy for product submissions and approvals.  Responsible for adhering to design controls and documenting all product development work in a Design History File.


·         Provide technical leadership to Biomedical Engineers and cross-functional teams within Client

·         Conceptual design of new drug delivery systems or product enhancements for pre-hospital emergency care products

·         Develop design inputs with associated justification for new product development

·         Lead risk analysis and risk management activities including human factors studies

·         Approve designs, test protocols, and reports

·         Justify new product development and develop project plans and budgets

·         Conduct business development research and due diligence activities

·         Conduct research and publish as appropriate

·         Comply with FDA Regulation and Guidance for Combination Products


·         Excellent leadership, interpersonal, and organizational skills

·         Conceptual and creative design skills

·         Human factors and usability engineering experience

·         Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.

·         Strong mathematical, analytical, and reasoning skills

·         Strong innovation skills

·         Strong creativity astuteness

·         Strong problem solving skills

·         Strong research skills

·         Strong in team work

·         Strong written and verbal communication and presentation skills.  Must be able to communicate effectively with staff at all levels in the organization.

·         Strong business acumen – demonstrates knowledge of market and competition

·         Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.

·         Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

·         Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously

·         Responds to requests for service and assistance with professionalism, courtesy, and confidence

Job Requirements


·         Must be able to travel 25% of the time.

·         Position requires regular onsite attendance, however, this position may be performed on a remote or telecommute basis on a temporary, short term basis.

·         Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site.

·         Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

·         Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

Help us improve CareerBuilder by providing feedback about this job: Report this Job.
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.