Senior Consultant (Biomedical Engineering)

About ESi

Engineering Systems Inc. (ESi) is a multidisciplinary engineering and scientific investigation and failure analysis firm. We primarily work with law firms, insurance companies, and manufacturers on small to large-scale projects to answer any technical questions they have. As a firm, our projects can entail investigating major transportation accidents, equipment failures, personal injury claims, and damage to residential or commercial structures. In many cases, we provide structural design services for repairs and retrofits to damaged or otherwise deficient residential, commercial, and industrial structures. The variety and depth of our project work creates a variety of fulfilling roles at ESi.

What We Can Offer You

• Medical, Dental & Vision
• Life Insurance/Voluntary Life Insurance/Universal Life Insurance
• Pet Insurance
• 401k with employer match
• Eligible for the Awards Program, Merit Bonus, and/or Annual Bonus
• Flexible Time Off (FTO) - encouraged to take 20 days of paid time off/year
• Career Growth
• Administrative & Technical Support
• Work/Life Balance
• 10 paid holidays (9 standard holidays and 1 floating holiday)
• Access to Wellbeats - on-demand fitness & well-being videos
• Full-size Gym
• 30-minute fitness break available in addition to 1-hour lunch break
• Wellness Reimbursement
• Business casual dress code and positive working environment
• Continuing education opportunities

About This Role

Responsible for planning, directing, and coordinating activities of client projects to ensure that goals and objectives of the projects are accomplished within the prescribed timeframe and funding parameters by performing the following duties personally and in coordination with other technical staff.

Key Responsibilities

• Conduct field investigations/inspections as assigned.
• Assist industrial clients in intellectual property matters related to medical devices.
• Provide technical leadership in failure analysis studies, safety and functionality evaluations, remediation strategies, risk-based engineering, or scientific marketing campaigns when 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, ensuring projects progress through fast-paced environments by establishing, reviewing, and adapting 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.

• Apply cutting edge imaging, experimental, and finite element methods to assess biomaterials, equipment, and implanted devices.
• Assess new technologies and characterize product performance to assist our 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.
• Investigate, examine, and simulate the intricate relationships that exist between people and medical devices related to orthopedics, spine, cardiology, neurology, biology, and combination.
• Oversee and execute challenging R&D initiatives pertaining to medical devices on behalf of our clients.
• Promote the group's technical capabilities to clients and the scientific community, developing new skills, increasing industry exposure, and gaining a broader clientele through our specialization in technical consulting.
• Monitor and report project progress, adjust plans as needed for optimal performance, and stakeholder satisfaction.
• Confer with project personnel to provide technical advice and resolve roadblocks.
• Coordinate project activities with FDA or other governmental agencies on behalf of our clients.

Education Requirements

• Master's degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Polymer Science, or a related field from an accredited university with 5-7 years of relevant work experience; OR a Bachelor's degree in Bioengineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Materials Science, Polymer Science, or a related field from an accredited university with 7-10 years of relevant work experience.

Experience Requirements

• Experience and familiarity with laboratory procedures and testing, as well as the ability to execute and report on high-quality laboratory work.
• Knowledge of analytical techniques related to the failure of metals, alloys, composites, polymers, and glasses.
• R&D experience applicable to medical devices is highly desirable.
• Hands-on experience in test method development, data acquisition, and measurement system integration.
• Demonstrated ability to decompose complex problems into actionable task lists by applying technical and critical thinking skills.
• Excellent technical (medical devices.) and critical thinking skills.
• Experience in failure, analysis, root cause analysis, and health, hazard, evaluations, focusing on post - market surveillance, recalls, and clinical studies of medical devices.
• Familiarity with mechanical and electromagnetic testing of implants, biomaterials, and animal/human tissue desirable.
• Direct experience in an applied R&D environment in medical devices is required, including working knowledge of medical device design control, and FDA regulatory requirements.
• Demonstrated capabilities in analytical, computational, and experimental modeling.
• Outstanding verbal and written communication skills to effectively communicate, highly technical issues to a non-technical audience while possessing the technical depth to collaborate with physicians and interact with regulatory bodies.
• Established client relationships in consulting business are highly desirable.
• Must be able to attract projects and continuously expand their business volume and have the skills to mentor a group of highly motivated professionals.

Skills Required

• Excellent written and oral communication skills.
• Exceptional interpersonal skills and ability to thrive in fast-paced environments.
• 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.
• Ability and desire to market ESi and grow the Biomedical Engineering specialty in the local and national markets.
• Project management expertise with experience managing multiple projects simultaneously.
• Strong foundation in systems engineering, data science and analysis, and mechanical engineering design.
• 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.

Certifications and Licensing

• Professional engineer licensure preferred
• RAC, PMP certifications are a plus

Computer Skills Required

• Intermediate/advanced skills in Excel
• Intermediate/advanced skills in word
• Intermediate expertise in the use of engineering tools for testing, data analysis, and systems modeling (Solidworks, SpaceClaim, LabView, R, MATLAB, PYTHON, Abaqus, ANSYS, COMSOL, STAR-CCM+, Fluent, Analyze 14.0, FiJi/imageJ, etc.)
• Knowledge of fundamental computational methods (Finite Element Analysis and Computational Fluid Dynamics).

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to stand, sit, walk, crawl, climb and lift up to 50lbs. Work may occasionally need to be performed at various heights, out of doors in varied climate extremes.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position includes work in a variety of environments including office, laboratory, industrial, construction and outdoors. Noise levels, temperature and weather conditions will vary according to the work environment. When appropriate employees will be required to use suitable PPE.

To all recruitment agencies: ESi does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of ESi without a prior written search agreement will be considered unsolicited and the property of ESi. Please, no phone calls or emails

It is the policy of ESI, as an equal opportunity employer, to attract and retain the best qualified individuals available, without regard to race/ethnicity, color, religion, national origin, gender, sexual orientation, age, disability, or veteran status. ESI is committed to recruiting, hiring, and promoting people with disabilities, as well as veterans. If you need assistance with completing the electronic application, please email your request to employment @ engsys.com