R&D Engineer - THV Devices

Hydrogen Group; Irvine (CA); On-site; USD 110,318,000 - 124,645,000; Full time

Job summary

Hydrogen Group seeks an R&D Engineer in Irvine, CA for a 12-month contract to support transcatheter aortic valve therapies. The role leads and supports projects for THV products, including design controls, manufacturing improvements, and labeling and training updates for global therapy expansion.

Responsibilities include providing engineering input on THV projects, developing solutions, and serving as SME on field performance.

Qualifications

• Bachelor's degree in engineering or scientific field plus 4 years of quality engineering experience, OR Master's degree in engineering or scientific field plus 3 years of quality engineering experience
• Life sciences industry experience (medical device, pharma, or biotech)
• Experience in new product development, with successful design experience from concept to commercialization, strongly preferred
• Master's degree in engineering, science, or a related discipline preferred

Responsibilities

• Provide engineering input to THV product projects, including application of design control and risk management
• Develop solutions to problems of moderate scope and complexity
• Serve as a subject matter expert on field performance of THV devices and the design features tied to key performance metrics
• Support product configuration changes, supply-chain driven manufacturing improvements, field performance investigations, and labeling and training updates

Skills

Design controls

Design verification

Design validation

Statistical techniques

Cross-functional collaboration

Leadership

Documentation

Written protocols

Medical device knowledge

Problem-solving

Education

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Tools

Test lab equipment

Job description

Hydrogen Group seeks an R&D Engineer in Irvine, CA for a 12-month contract to support transcatheter aortic valve therapies. The role leads and supports projects for THV products, including design controls, manufacturing improvements, and labeling and training updates for global therapy expansion.

Responsibilities include providing engineering input on THV projects, developing solutions, and serving as SME on field performance.