Engineering Lead, Catheter-Based Medical Devices

Nypro DR; Saint Petersburg, Tampa (FL, FL); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

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.

Skills

Catheter engineering

Technical leadership

Communication skills

Analytical problem solving

DFMEA

Cross-functional leadership

Regulatory knowledge

Education

Bachelor's degree in Mechanical Engine

Job description

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.