Senior Staff Consultant (BME)

Engineering Systems Inc•Norcross, GA

About The Position

Responsible for supporting the planning, directing, and coordinating activities of client projects and assisting senior technical staff to ensure that goals and objectives of the project(s) are accomplished within the prescribed time frame and funding parameters by performing the following duties personally and in coordination with other technical staff.

Requirements

Ph.D. in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Polymer Science, or a related field from an accredited university and up to 3 years of relevant work experience; or a Master's in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Polymer Science, or a related field from an accredited university and 5+ years of relevant subject matter work experience; or a Bachelor's in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Polymer Science, or a related field from an accredited university and 10+ years of relevant subject matter specific work experience
Willingness to become a testifying subject matter expert
Significant professional experience working within the medical device industry. 15+ years of experience in the industry preferred.
Experience and familiarity with Quality System Regulation 21 CFR Part 820 and ISO 13485.
Experience with risk management processes for medical devices, including experience with ISO 14971.
Experience and familiarity with FDA regulations. Experience with FDA audits/inspections preferred.
Experience and familiarity with laboratory procedures and testing, as well as the ability to execute and report on high-quality laboratory work.
Experience in forensic engineering of medical device failures. Knowledge of analytical techniques related to the failure of metals, alloys, composites, polymers, and glasses.
Excellent written and oral communication skills.
A team player actively engaging others in accomplishing project work and office goals within their home office and across offices and other technical disciplines throughout ESI.
Demonstrated ability to work cross-functionally and effectively integrate with diverse subject matter experts.
Demonstrated project management skills.
Ability and desire to market ESi and grow the Biomedical Engineering specialty in the local and national markets.
Ability and desire to drive toward eventually becoming a Principal consultant within the firm.
Ability to interact with coworkers and clients professionally and desire to develop business internally and externally.
Demonstrated leadership ability and desire to mentor more junior staff.
Intermediate/advanced skills in Excel
Intermediate/advanced skills Word
Intermediate expertise in the use of engineering tools for testing, data analysis, and systems modeling (LabView, R, MATLAB, PYTHON, Abaqus, ANSYS, COMSOL, STAR-CCM+, Fluent, LMS Amesim, Analyze 14.0, FiJi/imageJ, etc.)
Knowledge of fundamental computational methods (Finite Element Analysis and Computational Fluid Dynamics).

Nice To Haves

R&D and product development experience applicable to medical devices is highly desirable. Experience with product launch is preferred.
Hands-on experience in test method development, design of custom laboratory fixtures, data acquisition, and measurement system integration.
Demonstrated ability to decompose complex problems into actionable task lists by applying technical and critical thinking skills.
Professional Engineer Licensure, RAC, PMP certifications are a plus.

Responsibilities

Conduct field investigations/inspections as assigned.
Participate in forensic investigations supporting product liability litigation matters.
Assist industrial clients on matters related to medical devices.
Perform engineering analysis calculations, testing, and research and apply cutting-edge imaging, experimental, and analytical methods to assess biomaterials, surgical equipment, and medical devices.
Assist clients with their new product development endeavors or as part of failure analysis studies, safety and functionality evaluations, or scientific marketing campaigns when their devices are in clinical use.
Assist in marketing the group’s technical capabilities to clients and the scientific community.
Investigate, examine, and simulate the relationships between people and medical devices in specialized fields such as orthopaedics, spine, cardiology, neurology, ophthalmology, biology, and combination devices.
Promote the group's technical capabilities to clients and the scientific community, develop new skills, and increase industry exposure through specialization in technical consulting.
Assist in writing technical reports, perform research, and present technical material clearly and concisely to clients and team members.
Assist in preparing well-developed technical presentations and delivering them clearly and concisely to clients and team members.
Master and apply project management best practices to establish, review, and adapt assigned portions of project scopes, schedules, and budgets.
Ensure individual project responsibilities are resourced and managed to efficiently and effectively achieve overall project milestones and deliverables within budget constraints.
Confer with project leader and personnel to resolve roadblocks on assigned project responsibilities.

Benefits

Professional Development investment
Medical, Dental & Vision
Life Insurance/Voluntary Life Insurance/Universal Life Insurance
401k with employer match
Merit Bonus
Annual Bonus
Competitive Salary
Flexible Time Off (FTO) – encouraged to take at least 20 days of paid time off/year
Career Growth
Pet Insurance
Work/Life Balance
10 paid holidays (9 standard holidays and 1 floating holiday)
Access to Wellbeats – on-demand fitness & well-being videos
Wellness Reimbursement
30-minute fitness break available in addition to 1-hour lunch break
Business casual dress code and positive working environment
Continuing education opportunities