Design Assurance Engineer — Medical Devices & Validation

SGS Consulting; Colorado Springs (CO); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS Consulting seeks a biomedical engineer to participate in new product development, ensuring inputs are defined and design verification/validation meets requirements for medical devices.

You will review DHF documentation, assess trace matrices, and support risk management activities, collaborating with R&D to ensure compliance with standards such as FDA QSR, ISO 13485, and ISO 14971.

Qualifications

• Bachelor’s degree in mechanical or electrical engineering.
• 2–5 years in medical device industry.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.
• Experience with DHF reviews and design controls.

Responsibilities

• Participate independently on new product development projects and assure design verification/validation activities meet inputs requirements.
• Perform thorough reviews/audit of DHF documentation for capital and disposable medical devices.
• Review Requirements Trace Matrix and ensure traceability meets design control requirements.
• Sustain ongoing product projects ensuring inputs are met and verification/validation/risk activities are completed.
• Coordinate with R&D to align Risk Management files with applicable standards.
• Coordinate Health Risk Assessment when evaluating on-market product performance.

Skills

Medical devices

FDA QSR/Quality System

Design Control

ISO 14971

Risk Management

Usability

Electrical Safety

Software

Sterilization

Biocompatibility

Education

Bachelors in Mech Eng or EE

Job description

SGS Consulting seeks a biomedical engineer to participate in new product development, ensuring inputs are defined and design verification/validation meets requirements for medical devices.

You will review DHF documentation, assess trace matrices, and support risk management activities, collaborating with R&D to ensure compliance with standards such as FDA QSR, ISO 13485, and ISO 14971.