Engineering Lead - Catheter Systems

Nypro DR; Saint Petersburg, Tampa (FL, FL); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Jabil is seeking an Engineering Lead to drive architecture, requirements, risk management, and technology selection for catheter-based medical devices. You will lead cross-functional teams across engineering, quality, and manufacturing through the full product lifecycle, from concept to commercialization.

The role emphasizes experience in cardiovascular or related device development, with a focus on design controls, verification strategies, and manufacturing transfer.

Qualifications

• Bachelor's degree in Mechanical Engine
• Experience with medical device regulations and standards (IEC 60601, ISO 14971, ISO 10555, ISO 11070) and FDA Design Controls.

Responsabilités

• 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.

Connaissances

Catheter engineering

Technical leadership

Communication skills

Analytical problem solving

DFMEA

Cross-functional leadership

Regulatory knowledge

Formation

Bachelor's degree in Mechanical Engine

Description du poste

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

The Engineering Lead will serve as a key technical leader, driving product architecture, requirements development, risk management, technology selection, verification activities, and manufacturing transfer.

This individual will work cross-functionally with business unit directors/managers, engineering, quality, manufacturing, and commercial teams while serving as a primary technical interface with customers and external partners.

Experience in cardiovascular, electrophysiology, peripheral vascular, neurovascular, structural heart, or heart failure device development is highly desirable.

This role combines process development, product development, electromechanical design, and innovation leadership to support the full product lifecycle from concept development through commercialization and sustaining engineering.

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 Engine