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.
What Can Jabil Offer You?
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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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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