Design Assurance Engineer

SGS Consulting; Central City (CO); Presencial; USD 80 000 - 105 000; Tempo integral

Resumo da oferta

SGS Consulting in Colorado is seeking an experienced medical device professional to contribute to new product development, design verification and validation, and rigorous design controls.

You will independently review DHF documentation, maintain traceability via Requirements Trace Matrix, and collaborate with R&D to ensure risk management and compliance with standards. This role also emphasizes sustaining projects and change assessments to support market readiness.

Qualificações

• 2-5 years of experience in medical device industry
• Familiarity with FDA QSR, ISO 13485, and Medical Device Directive
• Experience with ISO 14971 risk management
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility requirements

Responsabilidades

• 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.
• 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.

Conhecimentos

2-5 years experience

FDA QSR

ISO 13485

Risk Management

Usability

Electrical Safety

Software

Biocompatibility

Formação académica

Bachelors in Mechanical or Electrical Eng

Descrição da oferta de emprego

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