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Senior System Verification Engineer
4 months ago
Position: Senior System Verification Engineer (V&V)
Location: Marlborough, MA (Onsite)
Length: 6+ months
Job Description:
Our client is looking for a Senior System Verification Engineer who will play a pivotal role in ensuring the quality and compliance of our client's medical aesthetic devices. The Senior System Verification Engineer will be responsible for verifying and validating laser systems, the role demands meticulous attention to detail, strong analytical skills, and the ability to collaborate effectively across various disciplines.
Duties and Responsibilities (but not limited to):
- Collaborate with cross-functional teams including DQA, NPI, and Regulatory groups to integrate, test, and evaluate laser systems.
- Provide hands-on engineering support for the development, integration, and verification of laser systems.
- Develop and execute V&V test plans, protocols, and reports to meet product requirements and regulatory standards.
- Conduct verification planning, assembly, and test preparation for engineering prototype medical systems.
- Troubleshoot optic, mechanic, hardware, and software issues for test data analysis.
- Assist in preparation for medical compliance tests and ensure adherence to FDA regulations and international standards.
- Provide input for product traceability analysis and risk mappings in relation to verification specifications.
- Utilize Defect Tracking System to report and resolve product issues effectively.
Qualifications:
- Bachelor’s degree in Electrical, Software Engineering, or related field.
- 5+ years of experience in verification and validation within the medical device industry.
- Proficiency in FDA regulations (i.e., 21 CFR 820.30, ISO 14791, IEC 62304, and IEC 60601).
- Familiarity with SW and System automated test tools.
- Strong analytical and problem-solving skills.
- Excellent documentation skills with a keen attention to detail.
- Ability to work independently and collaboratively within a team environment.
- Exceptional written and verbal communication skills.
- Organized and detail-oriented approach to work.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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