Design Assurance Engineer

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

Job Responsibilities:

• Participate independently on new product development project, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.
• Test method validation would be an element of assuring verification/validation is acceptable.
• Participate independently in doing thorough reviews/audit of Design History File(DHF) documentation for capital and disposable medical devices, including design plans, design inputs/outputs, verification/validation activities, design changes, and design transfer documentation.
• Participate independently on thorough reviews/audit Requirements Trace Matrix and assuring the trace matrix is accurate and meeting design control requirements for medical devices.
• Participate independently on sustaining product projects, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed..
• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Responsible for independently coordinating Health Risk Assessment team when needed for evaluation of on market product, must demonstrate efficient and effective analysis of situation, including problem definition and impact.
• Assess change requests of product for impact to design, determine supporting information required for implementation of changes.

Skills:

• 2-5 years’ experience preferably in medical device industry
• Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
• Experienced with ISO 14971, Risk Management
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.

Education/Experience:

• Bachelor's degree in mechanical engineering or electrical engineering