Engineering Lead - Catheter Systems

Jabil•Tampa, FL

4d•Onsite

About The Position

The Engineering Lead is a key technical leader responsible for product architecture, requirements development, risk management, technology selection, verification activities, and manufacturing transfer for catheter-based medical device systems. The role combines process development, product development, electromechanical design, and innovation leadership across the product lifecycle, from concept development through commercialization and sustaining engineering. The position works cross-functionally with business unit leaders, engineering, quality, manufacturing, and commercial teams, and serves as a primary technical interface with customers and external partners. Relevant device areas include cardiovascular, electrophysiology, peripheral vascular, neurovascular, structural heart, and heart failure technologies. The role is based on-site at Jabil’s St. Petersburg, Florida location. Work is split among office activities, laboratory development, prototype builds, customer interactions, and manufacturing support.

Requirements

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline.
Minimum 10 years of medical device development experience, including significant experience leading complex product development programs.
Strong catheter engineering background with demonstrated success leading complex development programs.
Demonstrated experience managing complete product development cycles from concept through commercialization.
Proven track record in catheter-based medical devices, cardiovascular technologies, or related minimally invasive therapeutic systems.
Experience leading multidisciplinary engineering teams and serving as technical lead on customer-facing programs.
Experience leading cross-functional teams in a regulated medical device environment.
Experience translating user and system requirements into product designs, verification plans, and technical deliverables.
Proficiency in risk management methodologies, including DFMEA and design controls.
Knowledge of applicable medical device regulations and standards, including IEC 60601, ISO 14971, ISO 10555, ISO 11070, FDA Design Controls, and applicable cardiovascular device standards.
Strong critical thinking, technical leadership, decision-making, analytical, and problem-solving skills, with a hands-on engineering approach.
Ability to communicate complex technical concepts to engineering teams, executive leadership, customers, and external stakeholders.

Nice To Haves

Master’s degree.
Working knowledge of devices used in cardiovascular, electrophysiology, peripheral vascular, neurovascular, structural heart, or heart failure applications.
Manufacturing process development and technology transfer experience, including catheter manufacturing technologies such as catheter extrusion and assembly, tipping and bonding, pull-wire and steering mechanisms, balloon catheter technologies, sensor integration, and electromechanical systems.
Hands-on experience troubleshooting electrical, mechanical, or electromechanical systems.
Experience supporting manufacturing equipment implementation, qualification, and process validation.
Familiarity with competitive market analysis, voice-of-customer activities, and front-end innovation processes.
Early-stage product development, feasibility assessment, and innovation leadership experience.

Responsibilities

Lead the design, development, integration, and commercialization of catheter-based medical device systems.
Develop and manage design control documentation, system requirements, product specifications, and traceability throughout the product lifecycle.
Lead risk management activities, including DFMEA, hazard analysis, and risk-based design decisions.
Drive concept generation, feasibility studies, technology evaluations, and selection of key components and subsystems.
Develop, integrate, and evaluate catheter systems incorporating mechanical, electrical, electronic, sensor, and programmable control technologies.
Oversee integration activities and ensure successful system-level performance.
Develop and execute verification strategies, engineering studies, and test methodologies to validate design requirements.
Analyze engineering data, troubleshoot technical issues, conduct root cause investigations, and implement corrective actions.
Evaluate new technologies for energy delivery systems and treatment parameters where applicable, including power, energy, dosage, waveform, and control strategies.
Lead design reviews, technical assessments, and engineering decision-making activities.
Support manufacturing process development, equipment qualification, process validation, and scale-up, including IQ/OQ/PQ as applicable.
Collaborate with manufacturing engineering, suppliers, and operations teams to transfer products into production.
Assess competitive technologies, emerging trends, and innovation opportunities in cardiovascular and catheter-based therapies.
Contribute to portfolio planning, innovation roadmaps, technical strategy, and technology acquisition recommendations.
Act as technical lead for customer-facing projects and maintain relationships with customer engineering teams.