Senior R&D Sustaining Engineer, Medical Devices

Planet Pharma; Irvine (CA); On-site; USD 62,000 - 76,000; Full time

Job summary

Planet Pharma in Irvine, CA, seeks a Senior Engineer, R&D Sustaining to manage lifecycle activities for Class III devices after market release. You will investigate field issues, drive design and process improvements, and ensure ongoing safety, reliability, and regulatory compliance.

You’ll lead RCAs, change control, and V&V efforts, collaborating with cross‑functional teams to maintain device performance and quality while satisfying stringent medical device standards.

Qualifications

• Bachelor’s degree in Engineering or Scientific field with 4 years of experience or Master’s with 3 years or Ph.D. with appropriate experience.
• Experience with ISO 13485, ISO 14971, FDA QMS regulations and medical device regulatory expectations.
• Experience developing or executing verification and validation protocols, engineering test methods, and technical reports.

Responsibilities

• Lead investigations of device field issues by analyzing performance data, customer feedback, and failure reports.
• Lead design and process changes, including design documentation updates and change control processes.
• Monitor device performance and quality metrics and drive actions to address deviations.
• Lead risk management activities including updates to FMEAs and hazard analyses.
• Develop, review, and execute engineering test plans, protocols, and reports with objective evidence.
• Maintain documentation of engineering changes, investigations, and regulatory submissions.

Skills

Root cause analysis

Engineering change control

V&V planning

Risk management

Data analysis

Python

Minitab

Excel

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Engineering or Scientific field

Master’s degree or equivalent

Ph.D. or equivalent

Tools

CAD software

Excel

Minitab

Job description

Planet Pharma in Irvine, CA, seeks a Senior Engineer, R&D Sustaining to manage lifecycle activities for Class III devices after market release. You will investigate field issues, drive design and process improvements, and ensure ongoing safety, reliability, and regulatory compliance.

You’ll lead RCAs, change control, and V&V efforts, collaborating with cross‑functional teams to maintain device performance and quality while satisfying stringent medical device standards.