R&D Engineer, Medical Devices – DHF Lead

ECI; Arden Hills (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

ECI seeks an experienced R&D Engineer to lead design control activities for class II/III medical devices. You will remediate DHFs, drive risk management, and manage verification/validation across multidisciplinary teams to ensure regulatory compliance.

Bachelor’s in Biomedical/Mechanical/Electrical engineering with 5+ years in medical devices is required. Proficiency with Minitab and electronic document systems is preferred.

Qualifications

• Minimum of 5 years direct experience in medical device industry.
• Bachelor’s Degree in Biomedical/Mechanical/Electrical engineering or equivalent.
• Broad regulatory knowledge in medical devices (Class II and III).
• Vast experience in writing/reviewing design control documents and compilation of DHFs.
• Experience with Minitab Statistical software.
• Experience with electronic documentation management systems (Windchill, Agile PLM, IBM Doors).

Responsibilities

• Review Design History Files (DHF) for compliance gaps and document remediation plan.
• Lead DHF remediation projects with cross-functional teams.
• Develop and update design control documentation, risk management deliverables, and reports.
• Coordinate documentation with R&D, design QA, regulatory, clinical affairs, and marketing.
• Develop, execute and summarize DVMP, design verification and validation protocols and reports.
• Develop and validate test methods and analyze results.
• Support product specifications development and testing.

Skills

Attention to detail

Communication

Problem solving

Interpersonal skills

Regulatory knowledge

Minitab

Office 365

Design controls

DHF remediation

Documentation

Education

Bachelor’s Degree in Biomedical/ Mechanical/ Electrical Engineering

Tools

Windchill

Agile PLM

IBM Doors

Job description

ECI seeks an experienced R&D Engineer to lead design control activities for class II/III medical devices. You will remediate DHFs, drive risk management, and manage verification/validation across multidisciplinary teams to ensure regulatory compliance.

Bachelor’s in Biomedical/Mechanical/Electrical engineering with 5+ years in medical devices is required. Proficiency with Minitab and electronic document systems is preferred.