Senior Managing Consultant (Biomedical Engineering)

Engineering Systems Inc•Miami, FL

2d•Hybrid

About The Position

The Senior Managing Consultant will lead and execute complex technical consulting, forensic engineering, R&D, and product evaluation engagements involving medical devices, life-sciences instrumentation, and multidisciplinary engineered systems. This role combines technical leadership, client development, project execution, and mentorship responsibilities to support the continued growth and scalability of the BMES practice. The ideal candidate brings a strong consulting orientation, systems-level engineering perspective, and demonstrated ability to lead large, technically complex projects in regulated environments.

Requirements

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
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.
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.
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.
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.

Nice To Haves

Professional Engineer (PE) licensure or equivalent technical credential preferred.
RAC, PMP certifications are a plus.
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.
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.

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 orthopaedic, 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.