Senior Medical Device DHF & Design Control Engineer

Theuniversityunion; Santa Clarita (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

ECI is seeking a Senior Remediation Engineer in Santa Clarita to lead DHF remediation and design control activities for Class II and III medical devices. You will guide cross-functional teams across documentation, risk management, usability and verification/validation, ensuring regulatory compliance and robust product lifecycle support.

The role requires 7+ years in the medical device industry, a B.S. in a related engineering field, and hands-on experience with design control, DHFs, and Minitab.

Qualifications

• Bachelor’s Degree in Biomedical/Mechanical/Electrical Engineering or equivalent.
• Broad regulatory knowledge in medical devices (Class II/III).
• Experience writing/reviewing DHFs and DHF compilation.
• Experience with Minitab statistical software.

Responsibilities

• Review Design History Files for DHF gaps and compliance.
• Prepare a gap assessment report with regulatory deficiencies.
• Develop remediation plans and lead DHF remediation projects.
• Coordinate documentation with R&D, QA, regulatory, clinical, and marketing.
• Develop risk management deliverables per ISO 14971 and usability docs per ISO 62366.
• Develop DVMP, design verification/validation protocols and reports.
• Ensure technical documentation meets regulatory requirements.

Skills

Accurate

Written communication

Problem solving

Interpersonal skills

Analytical thinking

Office 365

Minitab

Windchill

Agile PLM

Education

Bachelor’s Degree in Biomedical/Mechanical/Electrical Engineering

Tools

Minitab

Windchill

Agile PLM

IBM Doors

Office 365

Job description

ECI is seeking a Senior Remediation Engineer in Santa Clarita to lead DHF remediation and design control activities for Class II and III medical devices. You will guide cross-functional teams across documentation, risk management, usability and verification/validation, ensuring regulatory compliance and robust product lifecycle support.

The role requires 7+ years in the medical device industry, a B.S. in a related engineering field, and hands-on experience with design control, DHFs, and Minitab.