Senior R&D Engineer — Medical Devices (Sustaining)

ATR International; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

ATR International is seeking a Senior R&D Engineer to lead sustaining engineering efforts for commercialized neurovascular medical devices, ensuring design controls, risk management, and regulatory compliance are met.

The role provides technical leadership, mentors junior engineers, and drives cross-functional collaboration with Manufacturing, Quality, Regulatory Affairs, and Suppliers to deliver robust solutions.

Qualifications

• Bachelor's degree in mechanical/biomedical/materials engineering or related field.
• Master’s degree in engineering is preferred.

Responsibilities

• Lead sustaining & released product initiatives with design controls and regulatory compliance.
• Lead root-cause investigations and CAPAs using structured problem-solving methods.
• Author/review design specs, risk analyses (dfMEA/pfMEA), test methods, ECOs, and technical assessments.
• Design testing protocols, analyze data, and demonstrate changes meet design intent and regulatory standards.
• Drive design improvements, obsolescence mitigation, cost-reduction, and supply continuity.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations.

Skills

Sustaining leadership

Root-cause analysis

Design documentation

Data analysis

Cost optimization

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering

Master’s degree in an engineering discipline

Job description

ATR International is seeking a Senior R&D Engineer to lead sustaining engineering efforts for commercialized neurovascular medical devices, ensuring design controls, risk management, and regulatory compliance are met.

The role provides technical leadership, mentors junior engineers, and drives cross-functional collaboration with Manufacturing, Quality, Regulatory Affairs, and Suppliers to deliver robust solutions.