Engineer III, Systems Engineer
Engineer III, Systems Engineer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Verification & validation Engineer will have the following responsibilities:
- A strong technical background and experience g in the medical device industry (Translation of User/Business Needs to System Requirements Requirements Management System Architectural Development Functional Modeling Systems Integration Statistical Test Design Verification and Validation Hazards Analysis and Failure Modes Effects Analysis) and/or other engineering disciplines within the medical device industry.
- Lead verification and validation activities for new and existing medical devices ensuring compliance with FDA 510k ISO 13485 and FDA 21CFR Part 820 regulations.
- Working knowledge of IEC 60601-1 3rd Edition and related particular & collateral standards is essential.
- Document system and product-level requirements; managing changes via team review approval and release process.
- Develop and execute test protocols plans and reports for medical devices and cleaning/disinfecting products.
- Collaborate with cross-functional teams to ensure design and development activities meet regulatory and quality requirements.
- Conduct risk assessments and develop mitigation strategies for verification and validation activities.
- Prepare documentation and support regulatory submissions including FDA 510k submissions.
- Participate in design reviews and provide input on design for manufacturability and testability.
- Ensure all verification and validation activities are properly documented and maintained according to company quality systems.
- Stay up to date with industry trends standards and regulatory changes related to medical devices and cleaning/disinfecting products.
- Identify opportunities for process improvements and implement best practices in verification and validation.
- Train and mentor junior engineers on verification and validation processes and regulatory requirements.
- Experience in Risk Management a plus.
- Bachelors or masters degree in biomedical engineering Mechanical Engineering or a related field.
- Minimum of 3-5 years of experience in the medical device industry with a focus on R&D verification and validation.
- In-depth knowledge of FDA 510k submission process and requirements.
- Strong understanding of ISO 13485 and FDA 21CFR Part 820 regulations.
- Firsthand experience with verification and validation processes for medical devices.
- Experience with cleaning and disinfecting products for medical devices is highly desirable.
- Strong analytical and critical thinking skills.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team environment.
- Meticulousness and strong organizational skills.
- Proficiency in relevant software tools and technologies.
Employment Type
Full Time
