Staff Engineer I, THV Research and Development-THV

JenaValve Technology, Inc.; Irvine (CA); On-site; USD 90,000 - 115,000; Full time

Job summary

JenaValve Technology, Inc. is seeking a Staff Engineer for THV Research and Development in Irvine, California. This position entails developing novel subsystems for transcatheter heart valves and delivery systems, requiring a Bachelor's degree in Engineering and over 6 years of relevant experience.

The engineer will work independently and collaboratively, focusing on design, testing, and documentation in alignment with medical device industry standards. Strong communication and Solidworks skills are essential for success in this role.

Qualifications

• Minimum 6 years’ experience in R&D or product development of medical devices.
• Familiarity with 21CFR820 and ISO 13485 requirements.
• Hands-on experience in product development within an R&D lab.

Responsibilities

• Conceive, design, and develop components for heart valves and delivery systems.
• Create and review component drawings and specifications.
• Develop test methods and conduct testing.

Skills

Independent work

Cross-functional collaboration

Attention to detail

Problem analysis

Written communication

Solidworks/CAD skills

Project management

Statistical analysis

Education

Bachelor of Science in Engineering or Technical discipline

Tools

Solidworks

CAD software

Job description

Job Title

Staff Engineer, THV Research and Development

Supervisor/Manager Title

Director, Research and Development

Job Description Summary

Responsible for the development of novel subsystems and components for transcatheter heart valves and/or delivery systems.

Job Responsibilities

• Conceive, design, and develop components and subsystems of moderate/high complexity for transcatheter heart valves and/or delivery systems in accordance with quality system requirements and with minimal supervision.
• Create, review and/or approve component and subsystem drawings/specifications and documentation.
• Identify/evaluate vendors, procure components and develop component specifications.
• Develop test methods, conduct testing, and interpret data.
• Conduct engineering analyses and feasibility testing of components and subsystems to ensure proper fit and function.
• Conduct competitive product evaluation and product failure analyses.
• Partner with Quality to conduct risk analyses and develop/execute design verification activities.
• Partner with Manufacturing to develop manufacturing processes, tooling/fixtures, and transfer product/processes to manufacturing.
• Supervise R&D Technicians.

Qualifications

Required Education and Experience

• A Bachelor of Science degree in Engineering or Technical discipline with related work experience.
• Minimum of 6+ years’ experience in R&D or product development of medical devices, pharmaceutical or life science product technology. Level I, II, III DOE
• Familiarity with 21CFR820 and ISO 13485 requirements.
• Knowledge of the product development process and applicable Quality System requirements in the medical device industry.
• Demonstration of ability to work effectively and collaborate within cross-functional teams.
• Demonstration of ability to effectively communicate (in oral presentation and written documentation) test protocols, reports, and technical summaries to technical and non-technical personnel.
• Hands‑on experience in product development within an R&D lab environment.

Skills And Abilities Required For This Job

• Ability to work independently and in collaboration within cross-functional teams.
• Ability to manage multiple tasks in a timely manner with high attention to detail.
• Ability to build strong relationships at all levels of the organization, cross-functionally and with key external personnel.
• Demonstrated strength in problem analysis, judgment, decision making and critical thinking
• Strong written and verbal communication.
• Experience in developing product specifications based on user needs and writing design verification and validation protocols.
• Strong Solidworks/CAD skills.
• Project management skills.
• Knowledge of statistical analysis and applications.