Engineering Lead - Catheter Systems

Job 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, perform 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 activities including IQ/OQ/PQ as applicable.
• Collaborate with manufacturing engineering, suppliers, and operations teams to ensure successful transfer of products into production.
• Assess competitive technologies, emerging trends, and innovation opportunities within 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 strong relationships with customer engineering teams.

Required Skills

• Strong catheter engineering background with demonstrated success leading complex development programs to success.
• Excellent critical thinking, technical leadership, and decision-making capabilities.
• Ability to communicate complex technical concepts to engineering teams, executive leadership, customers, and external stakeholders.
• Strong analytical and problem-solving skills with a hands-on engineering approach.
• Experience translating user and system requirements into product designs, verification plans, and technical deliverables.
• Proficiency in risk management methodologies including DFMEA and design controls.
• Experience leading cross-functional teams in a regulated medical device environment.
• Knowledge of applicable medical device regulations and standards, including:
• IEC 60601
• ISO 14971
• ISO 10555
• ISO 11070
• FDA Design Controls
• Applicable cardiovascular device standards

Preferred Experience

• Working knowledge of devices used in Cardiovascular, electrophysiology, peripheral vascular, neurovascular, structural heart, or heart failure.
• Manufacturing process development and technology transfer and working experience with catheter manufacturing technologies. Including but not limited to:
• Catheter extrusion and assembly
• Tipping and bonding processes
• Pull-wire and steering mechanisms
• Balloon catheter technologies
• Sensor integration
• 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, VOC activities, and front-end innovation processes.

Education and Work History Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Systems Engineering, or related technical discipline required.
• Master's degree preferred.
• Minimum 10+ years of medical device development experience, including significant experience leading complex product 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.
• Early-stage product development, feasibility assessment, and innovation leadership experience strongly preferred.

Location

This role will be based on-site at the St. Petersburg, FL location and will split time between office activities, laboratory development, prototype builds, customer interactions, and manufacturing support.

Key Attributes

• Innovative mindset with strategic technical vision.
• Strong customer focus and business acumen.
• Ability to connect clinical needs with practical engineering solutions.
• Collaborative leadership style with demonstrated ability to influence across functions.
• Passion for advancing patient outcomes through breakthrough catheter and cardiovascular technologies.

Pay and benefits

Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K Match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&D, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunities

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