Senior Managing Consultant (Biomedical Engineering)

About ESi

Engineering Systems Inc. (ESi) is an engineering and scientific investigation and failure analysis firm. We partner primarily with law firms, insurance companies, and manufacturers to answer complex technical questions on projects ranging from small, focused investigations to large-scale, high-profile losses.

Our work spans a wide range of challenges, including major transportation accidents, equipment and product failures, personal injury claims, and damage to residential, commercial, and industrial structures. The variety, complexity, and real-world impact of our projects create deeply fulfilling and intellectually engaging careers for our consultants.

At ESi, you'll have the opportunity to shape your own path while being supported by a collaborative culture, national expertise, and industry-leading resources.

Why ESi

The BMES Practice evaluates medical, diagnostic, and drug-delivery products throughout the full product life cycle. Engineers work at the intersection of engineering, science, and regulatory compliance, supporting investigations, risk assessments, and product liability matters. The group applies testing, modeling, and data-driven analysis to prioritize patient safety, performance, and compliance.

Key Responsibilities

• Lead forensic investigations, failure analyses, and technical consulting engagements involving medical devices, biomaterials, surgical equipment, and complex engineered systems in support of product liability litigation and industrial clients.
• Conduct and oversee root-cause investigations involving mechanical, electrical, software, fluidic, optical, and integrated biomedical systems using advanced imaging, experimental, analytical, and numerical methods.
• Investigate and evaluate the interactions between patients, clinicians, and medical devices across orthopedic, spine, cardiovascular, neurological, ophthalmic, biologic, and combination-product applications.
• Assess product performance, safety, functionality, and reliability to support product development, risk assessment, scientific marketing, regulatory activities, and failure analysis studies for devices in development and clinical use.
• Lead and execute research and development initiatives for medical device clients, including technology assessment, product evaluation, and technical due diligence activities within regulated environments.
• Provide technical consulting and expert analysis related to intellectual property, regulatory compliance, FDA-related matters, and product liability litigation.
• Develop clear, scientifically rigorous, and defensible technical opinions, reports, presentations, and other deliverables for clients, attorneys, regulators, and other stakeholders.
• Direct multidisciplinary project teams and oversee project planning, staffing, budgeting, scheduling, execution, and resource allocation to ensure timely, high-quality deliverables and client satisfaction.
• Monitor project progress, resolve technical and operational challenges, and provide technical leadership and guidance to project personnel throughout all phases of execution.
• Coordinate technical activities and communications with clients, governmental agencies, including the FDA, and other external stakeholders on behalf of clients.
• Mentor, supervise, and develop junior and midcareer consultants through technical leadership, delegation, coaching, and professional development.
• Support business development and strategic growth initiatives through client relationship development, proposal preparation, technical visibility, publications, presentations, and cross-disciplinary collaboration.
• Promote and expand the technical capabilities and market presence of the BMES practice through scientific engagement, industry participation, and development of specialized consulting expertise.

Qualifications

Education / Certifications / Licenses Required

• Ph.D. or equivalent advanced degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, Materials Science, Computer Engineering, or a related technical discipline from an accredited university
• Professional Engineer (PE) licensure or equivalent technical credential preferred.
• RAC, PMP certifications are a plus.

Experience Required

• Approximately 10-20+ years of relevant experience in technical consulting, medical-device R&D, regulated product development, systems engineering, forensic engineering, or related industries.
• Deposition, trial, or expert-witness experience, including the ability to communicate technical findings effectively to attorneys, regulators, executive leadership, government panels, and non-technical audiences.
• Experience with BSL-1 and BSL-2 laboratory procedures and oversight of high-quality laboratory operations is desirable.
• Experience with medical imaging, processing, segmentation, and quantitative analysis tools.
• Experience with lab instruments, data acquisition, and automated testing.
• Working knowledge of software validation and creating traceable, reproducible workflows in regulated (FDA) environments.

Other Technical & Non-Technical Skills

• Demonstrated experience leading multidisciplinary technical programs, consulting engagements, or engineering organizations involving complex medical devices and engineered systems.
• Strong technical background in failure analysis, root-cause analysis, reliability engineering, risk assessment, systems diagnostics, post-market surveillance, recalls, and health hazard evaluations.
• Direct experience in medical device research and development, including working knowledge of design controls, quality systems, FDA regulatory requirements, and regulated product-development environments.
• Hands-on expertise in experimental, analytical, and computational evaluation of medical devices and biomedical systems, including benchtop, cadaveric, laboratory, and preclinical testing methodologies.
• Experience evaluating medical instrumentation, implants, biomaterials, tissue-device interactions, and integrated hardware/software or biomedical systems.
• Demonstrated capabilities in analytical, numerical, and experimental modeling, including systems-level analysis and test-method development.
• Experience supporting litigation, regulatory reviews, product liability matters, technical due diligence, expert witness activities, or other high-consequence technical investigations.
• Strong project-management, organizational, and leadership skills, including experience managing concurrent technical programs, multidisciplinary teams, budgets, schedules, and client expectations.
• Experience mentoring and developing technical staff within collaborative, multidisciplinary environments.
• Systems-oriented problem-solving skills with strong analytical judgment, intellectual curiosity, and the ability to operate effectively across diverse technical domains.
• Ability to balance technical rigor, client service, regulatory considerations, and business-development objectives in a consulting environment.
• Experience developing client relationships, securing technical projects, and contributing to strategic business growth is highly desirable.
• Familiarity with life sciences instrumentation, in vitro diagnostics, AI/ML-enabled medical technologies, software quality systems, and systems integration in regulated environments is desirable.
• High level of professionalism, integrity, accountability, and commitment to technical excellence, continuous learning, and professional development.
• Excellent written, verbal, and executive-level communication skills, with the ability to clearly explain highly technical concepts to both technical and non-technical stakeholders is required.
• A team player actively leading others in accomplishing project work and office goals within their home office, across offices, and in other technical disciplines throughout ESi is required.
• Market ESi and grow the Biomedical Engineering and Sciences specialty in the local and national markets, as well as develop business internally and externally will be required.
• Multilingual communication capabilities, scientific publications, and recognized technical visibility within industry or professional organizations are considered strong advantages, preferred.
• Demonstrated ability to become a Principal consultant within the firm.
• Model professional interactions with coworkers and clients and reinforce a culture of mutual respect and transparency.
• Intermediate/Advanced skills in Microsoft Excel, including data analysis, statistics, visualization, and automation.
• Intermediate/Advanced skills in Microsoft Word and PowerPoint for reporting, presentations, and documentation.
• Advanced expertise with engineering and scientific analysis tools (LabVIEW, MATLAB, Python, R, JMP, Minitab, SAS, Analyze, FIJI/ImageJ, etc.).
• Working knowledge of statistical modeling, reliability analysis, DOE, uncertainty analysis, and V&V.

What We Can Offer You

We believe great work happens when people feel supported, challenged, and trusted. Some of the benefits we offer include:

• Medical, Dental & Vision
• Life Insurance/Voluntary Life Insurance/Universal Life Insurance
• 401k with employer match
• Pet Insurance
• Flexible Time Off (FTO) - encouraged to take 20 days of paid time off/year
• 10 paid holidays (9 standard holidays and 1 floating holiday)
• Work/Life Balance in a collaborative working environment
• Wellness Reimbursement
• Career Growth & Continuing education opportunities

Total compensation includes a competitive base salary and bonus opportunity, with final pay determined by job-related factors such as experience, qualifications, individual performance, and overall company performance.

Physical Demands

This role requires frequently sitting or standing for extended periods of time and occasionally lifting and/or moving items weighing up to 50 pounds, with infrequent lifting up to 75 pounds. The work regularly requires bending, twisting, kneeling, crouching, and maintaining balance. This position frequently requires handling and operating specialized tools and equipment and working in a variety of physical positions, including occasionally accessing tight or confined spaces. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Work Environment

Work is performed in both office and field environments, including active construction sites, industrial settings, and damaged or compromised structures. The work environment may include exposure to varying noise levels, weather conditions, uneven terrain, and site-specific hazards. Use of personal protective equipment (PPE) may be required depending on site conditions. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

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.

ESi is an equal opportunity employer committed to attracting and retaining the most qualified individuals based on merit, experience, and skills. Employment decisions are made without regard to race, ethnicity, color, religion, national origin, sex, sexual orientation, age, disability, or veteran status. In accordance with applicable laws, ESi actively supports the employment of veterans and individuals with disabilities.